FLEX FIRST Registry Research Protocol

NCT05616104 | Completed FDA Device

• 1 other identifier: VMG-2022-001
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 4

Brief Summary

Prospective, observational study evaluating the clinical use and outcomes of the FLEX Vessel Prep (VP) system in arteriovenous fistulae or grafts presenting with clinical or hemodynamic abnormalities following 12 months post treatment.

Conditions

Arteriovenous Fistula; Arteriovenous Graft; Fistula; Arterial Occlusive Diseases

Outcome Measures

Primary Outcomes (2)

• Target Lesion Primary Patency Rate

  Defined as freedom from clinically driven target lesion re-intervention (CD-TLR) or access circuit thrombosis measured through 6-months post- procedure.

  6 months post procedure

• Serious Adverse Event Rate

  Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 1-month post-procedure.

  1 month

Study Arms (1)

FLEX Vessel Prep followed by angioplasty

Eligible subjects will be treated with the FLEX Vessel Prep system followed by balloon angioplasty.

Device: FLEX Vessel Prep System

Interventions

FLEX Vessel Prep System DEVICE

The FLEX Vessel Prep System 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 into the lesion, the balloon should be inflated according to the site's standard of care.

Also known as: Balloon Angioplasty

FLEX Vessel Prep followed by angioplasty

Eligibility Criteria

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

Study Population

Subjects with AVF/AVG stenosis who are eligible for FLEX/Angioplasty treatment

You may qualify if:

• Subject is ≥18 years of age.
• Subject is currently scheduled to undergo an endovascular intervention of arteriovenous fistula or graft due to clinical and hemodynamic abnormalities meeting the KDOQI Guidelines for AV access dysfunction:
• Elevated venous pressure during hemodialysis,
• Abnormal physical findings, and
• Unexplained decrease in delivered dialysis dose.
• Subject has a reasonable expectation of remaining on hemodialysis for ≥12 months.
• Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form.
• Subject understands the study and is willing and able to comply with the follow-up requirements.

You may not qualify if:

• Subject has a known or suspected systemic infection.
• Subject has a known or suspected infection of the hemodialysis graft.
• Subject has an untreatable allergy to radiographic contrast material.
• In the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment.

Sponsors & Collaborators

• VentureMed Group Inc.: lead

Study Sites (4)

Open Access Vascular Access

Miami, Florida, 33169, United States

Location

Minneapolis Vascular Surgery Center

New Brighton, Minnesota, 55112, United States

Location

Dialysis Access Institute

Orangeburg, South Carolina, 29118, United States

Location

Spartanburg Regional Health

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Fistula; Arterial Occlusive Diseases

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 15, 2022
• Study Start: November 29, 2022
• Primary Completion: February 1, 2025
• Study Completion: August 4, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)