Trial Outcomes & Findings for Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma (NCT NCT03005418)

Last Updated: 2026-07-29

Results Overview

Rate of primary patency at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

72 participants

Primary outcome timeframe

30 days from time of implantation

Results posted on

2026-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	All HAV The all HAV group consists of all patients with an arterial injury that was repaired with an ATEV/HAV, regardless of anatomical location of the repair or origin of the injury.
Overall Study STARTED	72
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Reasons for withdrawal
Measure	All HAV The all HAV group consists of all patients with an arterial injury that was repaired with an ATEV/HAV, regardless of anatomical location of the repair or origin of the injury.
Overall Study Adverse Event	6
Overall Study Death	12
Overall Study Lost to Follow-up	17
Overall Study ATEV Removal	10
Overall Study Withdrawal by Subject	4
Overall Study Other	3

Baseline Characteristics

72 patients were included in the all HAV group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All HAV Patients n=72 Participants The all HAV group consists of all patients with an arterial injury that was repaired with an ATEV/HAV, regardless of anatomical location of the repair or origin of the injury.
Age, Continuous	36.9 Age (years) n=9 Participants • 72 patients were included in the all HAV group.
Sex: Female, Male Female	20 Participants n=9 Participants
Sex: Female, Male Male	52 Participants n=9 Participants
Race/Ethnicity, Customized White	31 Participants n=9 Participants
Race/Ethnicity, Customized Black or African American	35 Participants n=9 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=9 Participants
Race/Ethnicity, Customized Other	5 Participants n=9 Participants
Region of Enrollment United States	68 Participants n=9 Participants
Region of Enrollment Israel	4 Participants n=9 Participants
Location of Vascular Injury Upper Extremity	15 participants n=9 Participants
Location of Vascular Injury Lower Extremity	51 participants n=9 Participants
Location of Vascular Injury Torso/Chest/Abdomen	6 participants n=9 Participants
Nature of Trauma Blunt	24 Participants n=9 Participants
Nature of Trauma Penetrating	48 Participants n=9 Participants
Injury Severity - Abbreviated Injury Scale Moderate	2 Participants n=9 Participants
Injury Severity - Abbreviated Injury Scale Serious	16 Participants n=9 Participants
Injury Severity - Abbreviated Injury Scale Severe	30 Participants n=9 Participants
Injury Severity - Abbreviated Injury Scale Critical	20 Participants n=9 Participants
Injury Severity - Abbreviated Injury Scale Not available	4 Participants n=9 Participants
Injury Etiology Injury (gunshot)	34 Participants n=9 Participants
Injury Etiology Motor vehicle accident	14 Participants n=9 Participants
Injury Etiology Industrial accident	3 Participants n=9 Participants
Injury Etiology Hospital acquired injury	12 Participants n=9 Participants
Injury Etiology Other	9 Participants n=9 Participants

PRIMARY outcome

Timeframe: 30 days from time of implantation

Population: This analysis includes all enrolled participants who underwent surgical implantation of the Human Acellular Vessel (HAV) across all injury cohorts (including community-acquired extremity injuries, hospital-acquired/iatrogenic injuries, and torso injuries).

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group	59 Participants

PRIMARY outcome

Timeframe: 30 days from time implantation

Population: This analysis focuses exclusively on the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.

Rate of primary patency at 30 days post-implantation, evaluated strictly within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the 30-day evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Primary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup	45 Participants

SECONDARY outcome

Timeframe: 30 days from time of implantation

Rate of secondary patency at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Secondary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the evaluation milestone, including vessels that became occluded but were successfully restored to patency via intervening endovascular or surgical re-intervention (e.g., thrombectomy, thrombolysis, or patch angioplasty).

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the All HAV Group	64 Participants

SECONDARY outcome

Timeframe: 30 days from time of implantation

The percentage of participants who remained entirely free from a confirmed, adjudicated infection of the implanted Human Acellular Vessel (HAV) conduit through the specified follow-up milestone, evaluated across the entire overall study population. An infection event is defined by clinical signs coupled with microbiologic confirmation from wound/perigraft cultures, or an independent clinical adjudication confirming a graft-specific infectious complication requiring targeted antibiotic therapy, surgical debridement, or explantation.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
HAV Infection Free Rate at Day 30 in the All HAV Group	70 Participants

SECONDARY outcome

Timeframe: 30 Days from time of implantation

Rate of successful limb salvage at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Limb salvage is defined as the preservation of the treated upper or lower extremity without the requirement for a major secondary amputation (defined as an amputation performed at or proximal to the wrist or ankle joints) during the follow-up window.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Limb Salvage Rate at Day 30 in the All HAV Group	65 Participants

SECONDARY outcome

Timeframe: 30 Days from time of implantation

Survival at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Under While-on-Treatment analysis all cases without any evidence of death are imputed as having survived.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Survival Rate at Day 30 in the All HAV Group	65 Participants

SECONDARY outcome

Timeframe: 12 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV primary patency through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimates of Long-term Primary Patency in the All HAV Group	60.1 Percentage of Participants Interval 36.9 to 77.1

SECONDARY outcome

Timeframe: 12 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimates of Long-term Secondary Patency in the All HAV Group	69.2 Percentage of Participants Interval 43.9 to 84.8

SECONDARY outcome

Timeframe: 12 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of Infection-fee HAV rates through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group	93.2 Percentage of Participants Interval 75.6 to 98.2

SECONDARY outcome

Timeframe: 12 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of limb salvage through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group	87.4 Percentage of Participants Interval 68.4 to 95.3

SECONDARY outcome

Timeframe: 12 months from implantation

Time-to-event analysis estimating the long-term cumulative probabilities of patient survival through the 12-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group	83.2 Percentage of Participants Interval 61.7 to 93.2

SECONDARY outcome

Timeframe: 36 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV primary patency through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimate of Long-term Primary Patency Rates in the All HAV Group	45.0 Percentage of Participants Interval 21.7 to 65.9

SECONDARY outcome

Timeframe: 36 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the All HAV Group	62.8 Percentage of Participants Interval 36.2 to 80.8

SECONDARY outcome

Timeframe: 36 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of infection-free HAV rates through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimate of Long-term Infection-free HAV Rates in the All HAV Group	93.2 Percentage of Participants Interval 75.6 to 98.2

SECONDARY outcome

Timeframe: 36 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of limb salvage through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimate of Long-term Limb Salvage Rates in the All HAV Group	84.3 Percentage of Participants Interval 62.1 to 94.0

SECONDARY outcome

Timeframe: 36 months from implantation

Time-to-event analysis estimating the long-term cumulative probabilities of patient survival through the 36-month follow-up period, evaluated across the entire overall study population. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimate of Long-term Patient Survival in the All HAV Group	79.0 Percentage of Participants Interval 52.9 to 91.7

SECONDARY outcome

Timeframe: 30 days from time of implantation

Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group	14 Participant with at least 1 intervention

SECONDARY outcome

Timeframe: 12 months from time of implantation

Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group	20 Participant with at least 1 intervention

SECONDARY outcome

Timeframe: 36 months from time of implantation

Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=72 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
HAV Interventions Required to Maintain/Restore Patency in the All HAV Group	23 Participant with at least 1 intervention

SECONDARY outcome

Timeframe: 30 days from time of implantation

Rate of secondary patency at 30 days post-implantation, evaluated within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Secondary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the 30-day evaluation milestone, including vessels that became occluded but were successfully restored to patency via intervening endovascular or surgical re-intervention (e.g., thrombectomy, thrombolysis, or patch angioplasty).

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Secondary Patency Rate of the Human Acellular Vessel (HAV) at Day 30 in the Extremity Community-Acquired Trauma Subgroup	48 Participants

SECONDARY outcome

Timeframe: 30 days from time of implantation

Population: This analysis focuses exclusively on the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise safety and efficacy evaluations within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.

The percentage of participants who remained entirely free from a confirmed, adjudicated infection of the implanted Human Acellular Vessel (HAV) conduit through the follow-up period. An infection event is defined by clinical signs (e.g., localized purulence, exposed graft, erythema) coupled with microbiologic confirmation from wound/perigraft cultures, or an independent clinical adjudication confirming a graft-specific infectious complication requiring targeted antibiotic therapy, surgical debridement, or explantation. Participants who did not experience an adjudicated graft infection are considered infection-free.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
HAV Infection-free Rates at Day 30 in the Extremity Community-Acquired Trauma Subgroup	53 Participants

SECONDARY outcome

Timeframe: 30 Days from time of implantation

Rate of successful limb salvage at 30 days post-implantation, evaluated within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Limb salvage is defined as the preservation of the treated upper or lower extremity without the requirement for a major secondary amputation (defined as an amputation performed at or proximal to the wrist or ankle joints) during the 30-day follow-up window.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Limb Salvage Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup	49 Participants

SECONDARY outcome

Timeframe: 30 Days from time of implantation

Survival at 30 days post-implantation, evaluated within the sub-cohort of participants presenting with non-iatrogenic, community-acquired extremity vascular trauma. Under While-on-Treatment analysis all cases without any evidence of death are imputed as having survived.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Survival Rate at Day 30 in the Extremity Community-Acquired Trauma Subgroup	50 Participants

SECONDARY outcome

Timeframe: 12 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV primary patency through the 12-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimates of Long-term Primary Patency in the Extremity Community-Acquired Trauma Subgroup	58.3 Percentage of Participants Interval 31.3 to 77.9

SECONDARY outcome

Timeframe: 12 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 12-month follow-up period, evaluated across the Extremity Community Acquired Injury Trauma Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the Extremity Community Acquired Injury Trauma Subgroup	65.7 Percentage of Participants Interval 36.3 to 84.1

SECONDARY outcome

Timeframe: 12 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of Infection-free HAV rates through the 12-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup	92.9 Percentage of Participants Interval 70.5 to 98.5

SECONDARY outcome

Timeframe: 12 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of limb salvage rates through the 12-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup	87.3 Percentage of Participants Interval 64.9 to 95.8

SECONDARY outcome

Timeframe: 12 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of patient survival through the 12-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 12 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup	86.8 Percentage of Participants Interval 64.6 to 95.5

SECONDARY outcome

Timeframe: 36 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV primary patency through the 36-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimates of Long-term Primary Patency in the Extremity Community-Acquired Trauma Subgroup	45.1 Percentage of Participants Interval 17.9 to 69.2

SECONDARY outcome

Timeframe: 36 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of maintaining HAV secondary patency through the 36-month follow-up period, evaluated across the Extremity Community Acquired Injury Trauma Subgroup. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimate of Long-term Secondary Patency Rates in the Extremity Community Acquired Injury Trauma Subgroup	55.8 Percentage of Participants Interval 24.6 to 78.4

SECONDARY outcome

Timeframe: 36 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of Infection-free HAV rates through the 36-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimates of Infection-free HAV Rates in the Extremity Community-Acquired Trauma Subgroup	92.9 Percentage of Participants Interval 70.5 to 98.5

SECONDARY outcome

Timeframe: 36 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of limb salvage rates through the 36-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimates of Limb Salvage Rates in the Extremity Community-Acquired Trauma Subgroup	82.5 Percentage of Participants Interval 53.8 to 94.2

SECONDARY outcome

Timeframe: 36 months from time of implantation

Time-to-event analysis estimating the long-term cumulative probabilities of patient survival through the 36-month follow-up period, evaluated across the pre-specified subgroup of participants enrolled with community-acquired vascular trauma restricted to the upper or lower extremities (n=54). To ensure precise efficacy evaluation within this clinical cohort, this specific analysis population excludes all study participants who presented with torso arterial trauma, as well as those treated for iatrogenic, hospital-acquired vascular injuries.. This metric reports the explicit Kaplan-Meier survival probability estimates and accompanying 95% Confidence Intervals calculated at the Month 36 milestones. Standard censoring rules apply to participants who died, withdrew early, or reached the data cutoff milestone without an event.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
Kaplan-Meier Estimates of Patient Survival in the Extremity Community-Acquired Trauma Subgroup	86.8 Percentage of Participants Interval 64.6 to 95.5

SECONDARY outcome

Timeframe: 30 days from time of implantation

Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup	10 Participant with at least 1 intervention

SECONDARY outcome

Timeframe: 12 months from time of implantation

Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup	15 Participant with at least 1 intervention

SECONDARY outcome

Timeframe: 36 months from time of implantation

Number of participants with at least 1 intervention required to maintain/restore patency of the HAV.

Outcome measures

Outcome measures
Measure	Extremity Community Acquired Injury Trauma Subgroup n=54 Participants All patients with a non-iatrogenic community acquired arterial injury repaired with an ATEV/HAV.
HAV Interventions Required to Maintain/Restore Patency in the Extremity Community Acquired Injury Trauma Subgroup	17 Participant with at least 1 intervention

Adverse Events

Acellular Tissue Engineered Vessel (ATEV)

Serious events: 48 serious events

Other events: 70 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Acellular Tissue Engineered Vessel (ATEV) n=72 participants at risk Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, will be implanted with the Humacyte ATEV as an interposition vessel or bypass using standard vascular surgical techniques.
Injury, poisoning and procedural complications Vascular graft thrombosis	16.7% 12/72 • Number of events 16 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Anastomotic stenosis	5.6% 4/72 • Number of events 7 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Vascular Graft Complication	4.2% 3/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Vascular Graft Stenosis	4.2% 3/72 • Number of events 3 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Vascular graft haemorrhage	2.8% 2/72 • Number of events 2 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Vascular graft occlusion	2.8% 2/72 • Number of events 2 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Vascular pseudoaneurysm ruptured	2.8% 2/72 • Number of events 2 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Accidental overdose	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Femur fracture	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Gun shot wound	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Post procedural Haemorrhage	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Pseudomeningocele	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Seroma	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Anastomotic complication	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Postoperative wound infection	5.6% 4/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Wound infection	5.6% 4/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Sepsis	2.8% 2/72 • Number of events 3 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Septic shock	1.4% 1/72 • Number of events 2 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Abscess limb	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Bone abscess	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations COVID-19 pneumonia	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Empyema	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Fracture infection	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Gangrene	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Graft infection	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Hematoma infection	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Influenza	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Meningitis bacterial	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Osteomyelitis	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Peritonitis bacterial	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Pneumonia	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Rhinovirus infection	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Soft tissue infection	2.8% 2/72 • Number of events 2 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Staphylococcal sepsis	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Urinary tract infection	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Urosepsis	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Vascular graft infection	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Wound infection pseudomonas	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Shock hemorrhagic	5.6% 4/72 • Number of events 5 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Arterial hemorrhage	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Arterial perforation	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Artery dissection	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Dry gangrene	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Hemotoma	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Hemorrhage	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Steal syndrome	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Extremity necrosis	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Musculoskeletal and connective tissue disorders Muscle necrosis	1.4% 1/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Musculoskeletal and connective tissue disorders Pain in extremity	1.4% 1/72 • Number of events 2 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Musculoskeletal and connective tissue disorders Compartment syndrome	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Fistula	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Cardiac disorders Cardiac arrest	4.2% 3/72 • Number of events 3 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Cardiac disorders Cardiac failure acute	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Cardiac disorders Cardiac failure congestive	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Cardiac disorders Cardio-respiratory arrest	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Cardiac disorders Mitral valve incompetence	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Cardiac disorders Ventricular tachycardia	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
General disorders Chills	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
General disorders Generalized edema	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
General disorders Malaise	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
General disorders Multiple organ dysfunction syndrome	2.8% 2/72 • Number of events 2 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
General disorders Peripheral swelling	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
General disorders Systematic inflammatory response syndrome	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Metabolism and nutrition disorders Hypervolemia	2.8% 2/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Metabolism and nutrition disorders Hyperkalemia	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.2% 3/72 • Number of events 3 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Blood and lymphatic system disorders Anemia	2.8% 2/72 • Number of events 2 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Blood and lymphatic system disorders Blood loss anemia	1.4% 1/72 • Number of events 2 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Gastrointestinal disorders Diverticulum intestinal hemorrhage	1.4% 1/72 • Number of events 2 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Gastrointestinal disorders Intestinal ischemia	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Gastrointestinal disorders Pancreatolithiasis	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Nervous system disorders Brain injury	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Nervous system disorders Cerebellar stroke	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Nervous system disorders Encephalopathy	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Nervous system disorders Parathesia	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Hepatobiliary disorders Acute hepatic failure	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Hepatobiliary disorders Gall bladder rupture	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Hepatobiliary disorders Ischemic cholecystitis	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Renal and urinary disorders Acute kidney injury	5.6% 4/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Investigations Blood culture positive	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Skin and subcutaneous tissue disorders Night sweats	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Skin and subcutaneous tissue disorders Skin necrosis	1.4% 1/72 • Number of events 1 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.

Other adverse events

Other adverse events
Measure	Acellular Tissue Engineered Vessel (ATEV) n=72 participants at risk Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, will be implanted with the Humacyte ATEV as an interposition vessel or bypass using standard vascular surgical techniques.
Injury, poisoning and procedural complications Vascular graft thrombosis	25.0% 18/72 • Number of events 24 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Anastomotic stenosis	8.3% 6/72 • Number of events 10 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Seroma	5.6% 4/72 • Number of events 5 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Vascular graft complication	5.6% 4/72 • Number of events 5 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Vascular graft occlusion	6.9% 5/72 • Number of events 5 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Injury, poisoning and procedural complications Vascular graft stenosis	5.6% 4/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Metabolism and nutrition disorders Hypocalcemia	12.5% 9/72 • Number of events 10 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Metabolism and nutrition disorders Hyperkalemia	11.1% 8/72 • Number of events 9 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Metabolism and nutrition disorders Hypophosphatemia	12.5% 9/72 • Number of events 10 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Metabolism and nutrition disorders Hypokalemia	9.7% 7/72 • Number of events 8 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Metabolism and nutrition disorders Lactic acidosis	9.7% 7/72 • Number of events 8 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Metabolism and nutrition disorders Hypomagnesmia	8.3% 6/72 • Number of events 6 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Metabolism and nutrition disorders Hyponatremia	6.9% 5/72 • Number of events 6 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Metabolism and nutrition disorders Hyperphosphatemia	6.9% 5/72 • Number of events 5 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Urinary tract infection	8.3% 6/72 • Number of events 7 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Postoperative wound infection	6.9% 5/72 • Number of events 6 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Wound infection	8.3% 6/72 • Number of events 6 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Infections and infestations Vascular graft infection	5.6% 4/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Blood and lymphatic system disorders Anemia	26.4% 19/72 • Number of events 22 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Blood and lymphatic system disorders Blood loss anemia	16.7% 12/72 • Number of events 13 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Blood and lymphatic system disorders Thrombocytopenia	13.9% 10/72 • Number of events 10 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Blood and lymphatic system disorders Leukocytosis	11.1% 8/72 • Number of events 8 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Blood and lymphatic system disorders Thrombocytosis	5.6% 4/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Gastrointestinal disorders Constipation	15.3% 11/72 • Number of events 13 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Gastrointestinal disorders Nausea	13.9% 10/72 • Number of events 11 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Gastrointestinal disorders Vomiting	8.3% 6/72 • Number of events 8 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 9/72 • Number of events 11 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	8.3% 6/72 • Number of events 6 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Musculoskeletal and connective tissue disorders Back pain	5.6% 4/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Musculoskeletal and connective tissue disorders Muscle spasms	5.6% 4/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Musculoskeletal and connective tissue disorders Muscle necrosis	5.6% 4/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Hypertension	13.9% 10/72 • Number of events 10 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Hypotension	8.3% 6/72 • Number of events 7 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Shock hemorrhagic	8.3% 6/72 • Number of events 7 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Vascular disorders Dep vein thrombosis	5.6% 4/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
General disorders Pyrexia	15.3% 11/72 • Number of events 13 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
General disorders Edema peripheral	13.9% 10/72 • Number of events 11 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
General disorders Pain	6.9% 5/72 • Number of events 6 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.6% 4/72 • Number of events 5 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	6.9% 5/72 • Number of events 5 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.6% 4/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Nervous system disorders Neuralgia	6.9% 5/72 • Number of events 5 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Nervous system disorders Paresthesias	6.9% 5/72 • Number of events 5 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Cardiac disorders Tachycardia	15.3% 11/72 • Number of events 12 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Psychiatric disorders Insomnia	12.5% 9/72 • Number of events 9 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Psychiatric disorders Anxiety	6.9% 5/72 • Number of events 5 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Psychiatric disorders Agitation	5.6% 4/72 • Number of events 4 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Renal and urinary disorders Acute kidney injury	13.9% 10/72 • Number of events 10 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.
Renal and urinary disorders Urinary retention	8.3% 6/72 • Number of events 6 • From the time of anesthesia induction for ATEV implantation to the conclusion of the Month 12 visit or early termination visit, unless an unresolved AE is still being followed. During the long-term follow-up period all SAEs considered related to ATEV, AESI, and AEs that result in a fatal outcome will be reported after the Month 12 Visit through the Month 36 Visit. An AE was defined as any untoward medical occurrence in a patient administered an Investigational Medicinal Product (IMP). Adverse Events did not necessarily have a causal relationship with the IMP. Therefore, an AE could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an IMP, whether or not related to the IMP.

Additional Information

Shamik Parikh, Chief Medical Officer

Humacyte Global, Inc.

Phone: (919) 313-9633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60