Trial Outcomes & Findings for Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study] (NCT NCT02532621)
NCT ID: NCT02532621
Last Updated: 2025-02-06
Results Overview
Percentage of subjects free from loss of access of the study graft for hemodialysis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
158 participants
Primary outcome timeframe
Six months of clinical follow-up following treatment assignment (enrollment)
Results posted on
2025-02-06
Participant Flow
Participant milestones
| Measure |
Venous InterGraft Connector (VIG)
This is a nonrandomized, single-arm study: All enrolled patients are assigned to the same treatment: AVG implantation using a VIG (study device) to create the venous anastomosis and standard suturing to create the arterial anastomosis of the implanted AVG.
Venous InterGraft Connector: The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
Sutured arterial anastomosis of an implanted vascular graft for hemodialysis: The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
Hemodialysis: The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.
|
|---|---|
|
Overall Study
STARTED
|
158
|
|
Overall Study
COMPLETED
|
132
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Venous InterGraft Connector (VIG)
This is a nonrandomized, single-arm study: All enrolled patients are assigned to the same treatment: AVG implantation using a VIG (study device) to create the venous anastomosis and standard suturing to create the arterial anastomosis of the implanted AVG.
Venous InterGraft Connector: The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
Sutured arterial anastomosis of an implanted vascular graft for hemodialysis: The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
Hemodialysis: The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
implanted graft abandoned before 6 months
|
12
|
|
Overall Study
last follow up performed outside window (<166 days) -censored
|
2
|
Baseline Characteristics
Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study]
Baseline characteristics by cohort
| Measure |
Venous InterGraft Connector (VIG)
n=158 Participants
This is a nonrandomized, single-arm study: All enrolled patients are assigned to the same treatment: AVG implantation using a VIG (study device) to create the venous anastomosis and standard suturing to create the arterial anastomosis of the implanted AVG.
Venous InterGraft Connector: The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
Sutured arterial anastomosis of an implanted vascular graft for hemodialysis: The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
Hemodialysis: The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.
|
|---|---|
|
Age, Continuous
|
62.6 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
123 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Diabetes mellitus
|
98 Participants
n=99 Participants
|
|
Obesity
|
51 Participants
n=99 Participants
|
|
Hypertension
|
89 Participants
n=99 Participants
|
|
Cardiovascular Disease
|
78 Participants
n=99 Participants
|
|
Number of prior permanent vascular access(s) for hemodialysis
0
|
64 Participants
n=99 Participants
|
|
Number of prior permanent vascular access(s) for hemodialysis
1
|
66 Participants
n=99 Participants
|
|
Number of prior permanent vascular access(s) for hemodialysis
2 or more
|
28 Participants
n=99 Participants
|
|
Duration of Hemodialysis
< 6 months
|
69 Participants
n=99 Participants
|
|
Duration of Hemodialysis
>= 6 months and <12 months
|
15 Participants
n=99 Participants
|
|
Duration of Hemodialysis
>= 12 months
|
59 Participants
n=99 Participants
|
|
Duration of Hemodialysis
NA (no current hemodialysis)
|
15 Participants
n=99 Participants
|
|
Current hemodialysis using a catheter
|
134 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Six months of clinical follow-up following treatment assignment (enrollment)Population: Intention-to-treat analysis population (All patients assigned to treatment using the study device). Patients withdrawn for reasons other than loss of cumulative patency were included in the analysis up until the time of withdrawal and were considered censored in the analysis, after withdrawal.
Percentage of subjects free from loss of access of the study graft for hemodialysis
Outcome measures
| Measure |
Venous InterGraft Connector (VIG)
n=158 Participants
This is a nonrandomized, single-arm study: All enrolled patients are assigned to the same treatment: AVG implantation using a VIG (study device) to create the venous anastomosis and standard suturing to create the arterial anastomosis of the implanted AVG.
Venous InterGraft Connector: The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
Sutured arterial anastomosis of an implanted vascular graft for hemodialysis: The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
Hemodialysis: The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.
|
|---|---|
|
Cumulative Patency at 6 Months
|
146 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Intention-to-treat (all patients assigned to treatment using the study device)
AV graft flow at end of implant procedure
Outcome measures
| Measure |
Venous InterGraft Connector (VIG)
n=158 Participants
This is a nonrandomized, single-arm study: All enrolled patients are assigned to the same treatment: AVG implantation using a VIG (study device) to create the venous anastomosis and standard suturing to create the arterial anastomosis of the implanted AVG.
Venous InterGraft Connector: The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
Sutured arterial anastomosis of an implanted vascular graft for hemodialysis: The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
Hemodialysis: The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.
|
|---|---|
|
Acute Device Success
|
158 Participants
|
SECONDARY outcome
Timeframe: Six monthsPopulation: Intention-to-treat (all patients assigned to treatment using the study device). Patients withdrawn for reasons other than loss of primary unassisted patency were included in the analysis up until the time of withdrawal and were considered censored in the analysis, according to usual convention, after withdrawal.
Percentage of subjects free from the occurrence of either access thrombosis or an access procedure performed to maintain access patency
Outcome measures
| Measure |
Venous InterGraft Connector (VIG)
n=158 Participants
This is a nonrandomized, single-arm study: All enrolled patients are assigned to the same treatment: AVG implantation using a VIG (study device) to create the venous anastomosis and standard suturing to create the arterial anastomosis of the implanted AVG.
Venous InterGraft Connector: The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
Sutured arterial anastomosis of an implanted vascular graft for hemodialysis: The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
Hemodialysis: The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.
|
|---|---|
|
Primary Unassisted Patency
|
95 Participants
|
SECONDARY outcome
Timeframe: Six monthsPopulation: Intention-to-treat.
Time from initial access placement to first graft cannulation for hemodialysis
Outcome measures
| Measure |
Venous InterGraft Connector (VIG)
n=158 Participants
This is a nonrandomized, single-arm study: All enrolled patients are assigned to the same treatment: AVG implantation using a VIG (study device) to create the venous anastomosis and standard suturing to create the arterial anastomosis of the implanted AVG.
Venous InterGraft Connector: The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
Sutured arterial anastomosis of an implanted vascular graft for hemodialysis: The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
Hemodialysis: The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.
|
|---|---|
|
Time to First Cannulation
|
20.1 days
Standard Deviation 23.5
|
SECONDARY outcome
Timeframe: Six monthsPopulation: intention to treat
Number of interventions required to maintain secondary patency
Outcome measures
| Measure |
Venous InterGraft Connector (VIG)
n=158 Participants
This is a nonrandomized, single-arm study: All enrolled patients are assigned to the same treatment: AVG implantation using a VIG (study device) to create the venous anastomosis and standard suturing to create the arterial anastomosis of the implanted AVG.
Venous InterGraft Connector: The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
Sutured arterial anastomosis of an implanted vascular graft for hemodialysis: The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
Hemodialysis: The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.
|
|---|---|
|
Interventions Required to Maintain Patency
One intervention to maintain AVG patency
|
33 Participants
|
|
Interventions Required to Maintain Patency
Two interventions to maintain AVF patency
|
14 Participants
|
|
Interventions Required to Maintain Patency
Three or more interventions to maintain AVG patency
|
8 Participants
|
|
Interventions Required to Maintain Patency
No interventions to maintain AVG patency
|
103 Participants
|
SECONDARY outcome
Timeframe: Six monthsPopulation: Intention-to-treat
Number and type of serious adverse events- death, emergent surgery, significant bleeding,graft infection, pseudoaneurysm
Outcome measures
| Measure |
Venous InterGraft Connector (VIG)
n=158 Participants
This is a nonrandomized, single-arm study: All enrolled patients are assigned to the same treatment: AVG implantation using a VIG (study device) to create the venous anastomosis and standard suturing to create the arterial anastomosis of the implanted AVG.
Venous InterGraft Connector: The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
Sutured arterial anastomosis of an implanted vascular graft for hemodialysis: The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
Hemodialysis: The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.
|
|---|---|
|
Serious Adverse Events (Secondary Endpoint Defined SAEs)
Death
|
3 Participants
|
|
Serious Adverse Events (Secondary Endpoint Defined SAEs)
AVG infection
|
6 Participants
|
|
Serious Adverse Events (Secondary Endpoint Defined SAEs)
significant bleeding
|
0 Participants
|
|
Serious Adverse Events (Secondary Endpoint Defined SAEs)
emergent surgery
|
0 Participants
|
|
Serious Adverse Events (Secondary Endpoint Defined SAEs)
pseudoaneurysm
|
0 Participants
|
|
Serious Adverse Events (Secondary Endpoint Defined SAEs)
No protocol-defined SAEs
|
149 Participants
|
Adverse Events
Venous InterGraft Connector (VIG)
Serious events: 58 serious events
Other events: 37 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Venous InterGraft Connector (VIG)
n=158 participants at risk
This is a nonrandomized, single-arm study: All enrolled patients are assigned to the same treatment: AVG implantation using a VIG (study device) to create the venous anastomosis and standard suturing to create the arterial anastomosis of the implanted AVG.
Venous InterGraft Connector: The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
Sutured arterial anastomosis of an implanted vascular graft for hemodialysis: The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
Hemodialysis: The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.
|
|---|---|
|
Infections and infestations
graft/access circuit infection
|
3.8%
6/158 • Number of events 6 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Surgical and medical procedures
Emergent surgery
|
0.00%
0/158 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Vascular disorders
Significant bleeding
|
0.00%
0/158 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Vascular disorders
Pseudoaneurysm
|
0.00%
0/158 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
sepsis
|
2.5%
4/158 • Number of events 4 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
cellulitis
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
Abscess, general
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
Bacteremia
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
gangrene
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
other infection (not AVG)
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
intervertebral discitis
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
sinusitis
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
Subcutaneous abscess
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
urosepsis
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
General disorders
death
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
General disorders
pyrexia
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
General disorders
asthenia
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
General disorders
hemorrhage, catheter site
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
General disorders
chest discomfort
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
General disorders
chest pain
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
General disorders
peripheral swelling
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
General disorders
stent malfunction
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Cardiac disorders
acute myocardial infarction
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Cardiac disorders
atrial fibrillation
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Cardiac disorders
cardiac failure
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Cardiac disorders
cardiac failure, acute
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Cardiac disorders
cardiac failure, chronic
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Cardiac disorders
cardiac failure, congestive
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Cardiac disorders
cardio-respiratory arrest
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Cardiac disorders
coronary artery disease
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Vascular disorders
steal syndrome
|
2.5%
4/158 • Number of events 6 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Vascular disorders
hypertensive emergency
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Vascular disorders
hypotension
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Vascular disorders
ischemia
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Vascular disorders
malignant hypertension
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Metabolism and nutrition disorders
fluid overload
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Metabolism and nutrition disorders
failure to thrive
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Nervous system disorders
cerebral hemorrhage
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Nervous system disorders
cerebrovascular accident
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Nervous system disorders
Diziness
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Nervous system disorders
embolic stroke
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Nervous system disorders
encephalopathy
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Gastrointestinal disorders
GI hemorrhage
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Gastrointestinal disorders
impaired gastric emptying
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Gastrointestinal disorders
intestinal ischemia
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Gastrointestinal disorders
melena
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary thrombosis
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Surgical and medical procedures
blood pressure management
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Surgical and medical procedures
hospitalization, general
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Surgical and medical procedures
parathyroidectomy
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Surgical and medical procedures
amputation, toe
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Injury, poisoning and procedural complications
pain, procedure
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Injury, poisoning and procedural complications
vascular graft complication
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Injury, poisoning and procedural complications
fracture, wrist
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Renal and urinary disorders
acute kidney injury
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Renal and urinary disorders
hematuria
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Renal and urinary disorders
urinary retention
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Blood and lymphatic system disorders
anemia
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Hepatobiliary disorders
hepatic failure
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Investigations
heart rate decrease
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Musculoskeletal and connective tissue disorders
pain, extremity
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Psychiatric disorders
mental status change
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Skin and subcutaneous tissue disorders
facial swelling
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
Other adverse events
| Measure |
Venous InterGraft Connector (VIG)
n=158 participants at risk
This is a nonrandomized, single-arm study: All enrolled patients are assigned to the same treatment: AVG implantation using a VIG (study device) to create the venous anastomosis and standard suturing to create the arterial anastomosis of the implanted AVG.
Venous InterGraft Connector: The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
Sutured arterial anastomosis of an implanted vascular graft for hemodialysis: The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
Hemodialysis: The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.
|
|---|---|
|
General disorders
swelling, implant site
|
5.1%
8/158 • Number of events 8 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
General disorders
chest pain
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
General disorders
pain, implant site
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
General disorders
pyrexia
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
General disorders
pain, suprapubic
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Vascular disorders
vascular steal syndrome
|
5.1%
8/158 • Number of events 8 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Vascular disorders
hemorrhage
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Vascular disorders
diabetic microangiopathy
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Vascular disorders
hypotension
|
0.63%
1/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Vascular disorders
coldness, peripheral
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Injury, poisoning and procedural complications
contusion
|
1.9%
3/158 • Number of events 4 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Injury, poisoning and procedural complications
graft complication
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Injury, poisoning and procedural complications
AV site complication
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Injury, poisoning and procedural complications
fracture
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Injury, poisoning and procedural complications
incision site vesicles
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Injury, poisoning and procedural complications
hemorrhage, post procedure (not serious)
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Injury, poisoning and procedural complications
seroma
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Injury, poisoning and procedural complications
pseudoaneurysm (not requiring treatment)
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Nervous system disorders
hypoasthesia
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Nervous system disorders
neuralgia
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Nervous system disorders
paresthesia
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Nervous system disorders
diziness
|
0.63%
1/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Nervous system disorders
sciatica
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Gastrointestinal disorders
vomiting
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Gastrointestinal disorders
colitis, microscopic
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Gastrointestinal disorders
diarrhea
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Skin and subcutaneous tissue disorders
erythema
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Skin and subcutaneous tissue disorders
skin exfoliation
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
conjunctivitis
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
infection, minor
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Infections and infestations
diverticulitis
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Musculoskeletal and connective tissue disorders
pain, extremity
|
1.3%
2/158 • Number of events 2 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Musculoskeletal and connective tissue disorders
stiffness, musculoskeletal
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Investigations
ER examination
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Reproductive system and breast disorders
breast pain
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.63%
1/158 • Number of events 1 • Adverse event data were collected from the date of enrollment (date of index procedure) through 6 months or until the occurrence of a terminal study event (death, lost to follow up, withdrew from the study, abandonment of implanted graft), whichever occurred first.
Serious adverse events were to be initially reported to the Sponsor within 24 hours of discovery by the investigator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results proposed to be published or presented shall be submitted to Sponsor for review and comment at least 45 days prior to submission to allow Sponsor to protect its rights to any patentable inventions disclosed and to permit Sponsor to request removal of any Confidential Information provided by Sponsor. Any such publication or presentation shall acknowledge, as appropriate, the contribution of Sponsor, its employees, agents and representatives.
- Publication restrictions are in place
Restriction type: OTHER