CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 144 enrolled
Drug / intervention
VasQdevice
Likely dose
VasQ external support device for arteriovenous fistulaAI-extracted
Key inclusion· 3
  • ✓Patients referred for creation of a new brachiocephalic fistula (main cohort) or forearm fistula (supplementary cohort) who consent to participate
  • ✓Age 18-80 years
  • ✓Willing and able to attend follow-up visits over 24 months
Key exclusion· 13
  • ✕Revision surgery of an existing fistula (planned index procedure must be new fistula creation)
  • ✕Main cohort: target artery <2.5 mm or >6 mm inner diameter; Supplementary cohort: target artery <2 mm or >4.1 mm inner diameter on preoperative ultrasound
  • ✕Main cohort: target vein <2.5 mm inner diameter; Supplementary cohort: target vein <2 mm inner diameter on preoperative ultrasound
  • ✕Significant stenosis (≥50%) in target vein on side of surgery (preoperative ultrasound from planned anastomosis site to axillary vein)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03242343
NCT03242343N/ACompleted
CompareCT.gov

A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula

Laminate Medical Technologies·interventional·Posted Aug 8, 2017·Updated May 27, 2026

In Brief

A clinical study evaluating VasQ for Arterio-Venous Fistula and 7 related conditions. Completed, enrolled 144 participants across 15 sites.

Detailed Summary

This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow. All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArterio-Venous Fistula, ESRD, Steal Syndrome, Aneurysm, Renal Failure, Renal Disease, Diabetes Mellitus, Kidney Failure
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 8, 2017
Enrollment StartNov 29, 2017
Primary CompletionOct 8, 2020
Study CompletionApr 3, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.9 years ago

Interventions

VasQdevice

An external support device for AV fistula