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

NCT05034939 | Completed Results FDA Device

• 1 other identifier: VMG-2021-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Arteriovenous Fistula Stenosis

Outcome Measures

Primary Outcomes (1)

• Primary Safety Endpoint: Serious Adverse Event Rate

  Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 30 days post- procedure.

  30 Days

Study Arms (2)

FLEX Vessel Prep System followed with PTA (TEST arm)

ACTIVE COMPARATOR

FLEX Vessel Prep System is used to create circumferential, continuous micro-incisions along the length of the stenosis by performing a retrograde pullback through the lesion. Following FLEX, standard balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care.

Device: FLEX Vessel Prep System

PTA only (CONTROL arm)

ACTIVE COMPARATOR

Standard Balloon angioplasty is performed with an uncoated PTA balloon sized to meet the reference vessel diameter, according to its corresponding instructions for use. Once advanced to the lesion, the balloon should be inflated according to the site's standard of care.

Device: Angioplasty

Interventions

FLEX Vessel Prep System DEVICE

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.

FLEX Vessel Prep System followed with PTA (TEST arm)

Angioplasty DEVICE

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.

PTA only (CONTROL arm)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥21 years of age.
• Patient has a life expectancy of ≥12 months.
• Patient has a native AV fistula created ≥ 60 days prior to the index procedure.
• The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four-week period.
• Patient has a de novo and/or non-stented restenotic lesion located between approximately 2 cm proximal to the arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis.
• Patient has a target lesion (which may include a tandem lesion) that is ≤ 100 mm in length (by visual estimate).
• Note: Tandem lesions may be enrolled provided they meet all of the following criteria:
• Separated by a gap of ≤ 30mm (3 cm).
• Total combined lesion length, including 30 mm gap, ≤ 100 mm.
• Able to be treated as a single lesion.
• Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate)
• Patient underwent successful crossing of the target lesion with the guidewire.
• Patient provides written informed consent prior to enrollment in the study.
• Patient is willing to comply with all follow-up evaluations at specified times.

You may not qualify if:

• Patient is pregnant or breastfeeding.
• Patient is receiving immunosuppressive therapy.
• Patient has undergone prior intervention of access site within 30 days of index procedure.
• Patient with anticipated conversion to peritoneal dialysis.
• Patient has an infected AV access or systemic infection.
• Patient has planned surgical revision of access site.
• Patient with secondary non-target lesion requiring treatment within 30 days post index procedure.
• Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion.
• Patient with target AVF or access circuit which previously had thrombectomy within last 30 days.
• Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.
• Patient with target lesion located central to the axillosubclavian junction.
• Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access.
• Patient has presence of pseudoaneurysm or aneurysm requiring surgical revision at the target lesion site.
• Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated.
• Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy.

Sponsors & Collaborators

• VentureMed Group Inc.: lead

Study Sites (7)

AKDHC Medical Research Services

Phoenix, Arizona, 85012, United States

Location

Open Access Vascular Access

Miami, Florida, 33169, United States

Location

Minneapolis Vascular Surgery Center

New Brighton, Minnesota, 55112, United States

Location

Metrolina Nephrology Associates

Charlotte, North Carolina, 28208, United States

Location

North Carolina Nephrology

Raleigh, North Carolina, 27610, United States

Location

Dialysis Access Institute

Orangeburg, South Carolina, 29118, United States

Location

Dallas Nephrology Associates

Dallas, Texas, 75235, United States

Location

MeSH Terms

Interventions

Angioplasty

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Results Point of Contact

• Title: Vice President, Clinical, Regulatory & Quality
• Organization: VentureMed Group, Inc.

jschweiger@venturemedgroup.com

763-296-2021

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 5, 2021
• Study Start: September 2, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)