Trial Outcomes & Findings for VasQ External Support for Arteriovenous Fistula (NCT NCT03242343)

NCT ID: NCT03242343

Last Updated: 2026-05-27

Results Overview

Proportion of patients with freedom from intervention since device placement

Recruitment status

COMPLETED

Study phase

Target enrollment

144 participants

Primary outcome timeframe

6 months post AVF creation

Results posted on

2026-05-27

Participant Flow

Participant milestones

Participant milestones
Measure	VasQ Device Implantation Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints. Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints. VasQ: An external support device for AV fistula
Overall Study STARTED	144
Overall Study COMPLETED	144
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VasQ External Support for Arteriovenous Fistula

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VasQ Device Implantation n=144 Participants Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints. Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints. VasQ: An external support device for AV fistula
Age, Continuous	58.9 years STANDARD_DEVIATION 11.4 • n=51 Participants
Sex: Female, Male Female	56 Participants n=51 Participants
Sex: Female, Male Male	88 Participants n=51 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=51 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	122 Participants n=51 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=51 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=51 Participants
Race (NIH/OMB) Asian	1 Participants n=51 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=51 Participants
Race (NIH/OMB) Black or African American	51 Participants n=51 Participants
Race (NIH/OMB) White	77 Participants n=51 Participants
Race (NIH/OMB) More than one race	7 Participants n=51 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=51 Participants

PRIMARY outcome

Timeframe: 6 months post AVF creation

Proportion of patients with freedom from intervention since device placement

Outcome measures

Outcome measures
Measure	VasQ Device Implantation n=134 Participants Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints. Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints. VasQ: An external support device for AV fistula
Primary Patency of AVF	88 Participants

PRIMARY outcome

Timeframe: Device implantation to 6 months post AVF creation

Number of participants with access related steal syndrome, AVF infection, AVF aneurysm, or seroma

Outcome measures

Outcome measures
Measure	VasQ Device Implantation n=144 Participants Main study cohort: Prospective, multi-center, single-arm, open label, enrolling patients referred to surgical creation of new brachiocephalic fistula (BCF). The VasQ will be applied to the AV fistula in all patients. The primary effectiveness endpoint for this trial will be measured at 6 months and compared to a performance goal (PG). Safety will compare descriptively between AE rates for Steal, Infection, Aneurysm and Seroma. Patients will be followed up for an additional 18 months for a total of 2 years. Additionally, this trial has several secondary endpoints. Supplementary study cohort: 15 patients will be prospectively enrolled which are referred to surgical creation of a new forearm arteriovenous fistula. VasQ will be applied to the AV fistula in all patients. Patients will be followed in the same manner as in the Main study cohort, however, the data will be reported separately and not be part of the analysis sets for the study primary and secondary endpoints. VasQ: An external support device for AV fistula
Number of Participants With Access Related Safety Events	4 Participants

Adverse Events

VasQ Device Implantation

Serious events: 9 serious events

Other events: 0 other events

Deaths: 21 deaths

Serious adverse events

Serious adverse events
Measure	VasQ Device Implantation n=144 participants at risk All patients in the study VasQ: An external support device for AV fistula
Respiratory, thoracic and mediastinal disorders COVID-19	6.2% 9/144 • 2 years
Renal and urinary disorders Kidney transplant	4.2% 6/144 • 2 years
Cardiac disorders Congestive heart failure	4.2% 6/144 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Orit Yardeb, VP Clinical and Regulatory Affairs

Laminate Medical Technologies

Phone: +97236344246

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place