FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)

Arteriovenous Fistula Stenosis Clinical Trial

Official title: FLEX Vessel Prep Prior to the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae

Status Completed

Clinical Trial Summary

A prospective, multi-center, randomized (1:1) clinical study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) (study arm) vs PTA alone (control arm) for the treatment of obstructive lesions in the native arteriovenous dialysis fistulae.

Clinical Trial Description

This is a prospective, multi- center, randomized (1:1) clinical study evaluating the FLEX Vessel Prep System followed with PTA (TEST arm) vs PTA alone (CONTROL arm) for the treatment of de novo or non-stented restenotic obstructive lesions up to 100 mm in length located in the arteriovenous dialysis fistulae in an upper extremity. The objective is to evaluate and compare the serious adverse event rate at 30 days and primary patency at 6 months when using FLEX Vessel Prep System prior to PTA vs. PTA alone for treatment of obstructive lesion of native arteriovenous fistulae in the upper extremity. Enrollment will continue until complete data sets are collected for up to 75 subjects from up to 7 sites in the US. ;

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Stenosis
• Fistula

• NCT number: NCT05034939
• Study type: Interventional
• Source: VentureMed Group Inc.
• Status: Completed
• Phase: N/A
• Start date: September 2, 2021
• Completion date: December 1, 2022