CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
FLEX Vessel Prep System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT05034939
NCT05034939N/ACompleted
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FLEX Vessel Prep Prior to the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae

VentureMed Group Inc.·interventional·Posted Sep 5, 2021·Updated Jul 3, 2025

In Brief

A clinical study evaluating FLEX Vessel Prep System and Angioplasty for Arteriovenous Fistula Stenosis. Completed, enrolled 75 participants across 7 sites.

Detailed Summary

A prospective, multi-center, randomized observational post-market study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) vs PTA alone for the treatment of obstructive lesions in the native arteriovenous dialysis fistulae.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArteriovenous Fistula Stenosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 5, 2021
Enrollment StartSep 2, 2021
Primary CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.8 years ago

Interventions

FLEX Vessel Prep Systemdevice

The FLEX Vessel Prep System™ is an over-the-wire sheathed catheter with a three-strut treatment element near the distal tip. As the device is pulled back in a retrograde fashion through the target lesion, the Treatment Element "flexes" providing continuous engagement along the lesion to create controlled depth micro-incisions.

Angioplastydevice

The brand and type of PTA balloon(s) used will be at the discretion of the treating physician and used according to its Instructions for Use (IFU). PTA balloons consist of an over-the-wire catheter with a balloon fixed at the distal tip. Within the lesion the balloon is inflated to a pressure that allows full effacement.