FLEX FIRST Registry Research Protocol | Clinical Trial

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Open Access Vascular Access, Miami, Florida, United States

About this study

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 in real-world subjects per the Institution's standard practice and at 1-, 6-, and 12-months following treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Other names: Balloon Angioplasty

Primary outcomes

Target Lesion Primary Patency Rate

Time frame: 6 months post procedure

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

Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

VentureMed Group Inc.

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Nov 15, 2022
Registry last updated: Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed