NCT05034939

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: VentureMed Group Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective randomized (1:1) post-market observational study evaluating the FLEX Vessel Prep System followed with PTA vs PTA alone 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.

Conditions

• Arteriovenous Fistula Stenosis

Interventions

Type	Name	Description
DEVICE	FLEX Vessel Prep System	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.
DEVICE	Angioplasty	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.

Timeline

• Start date: 2021-09-02
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2021-09-05
• Last updated: 2025-07-03
• Results posted: 2025-07-03

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study