FLEX FIRST Registry Research Protocol

VentureMed Group Inc.130 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Arteriovenous Fistula Arteriovenous Graft Fistula Arterial Occlusive Diseases

Interventions

FLEX Vessel Prep SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is ≥18 years of age. 2. 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. 3. Subject has a reasonable expectation of remaining on hemodialysis for ≥12 months. 4. Subject is legally competent, informed of the study, voluntarily agrees to participate, and signs the informed consent form. 5. Subject understands the study and is willing and able to comply with the follow-up requirements. Exclusion Criteria: 1. Subject has a known or suspected systemic infection. 2. Subject has a known or suspected infection of the hemodialysis graft. 3. Subject has an untreatable allergy to radiographic contrast material. 4. In the opinion of the operating physician, the subject's hemodialysis access is unsuitable for endovascular treatment.

Locations (4)

Open Access Vascular Access

Miami, Florida, United States

Minneapolis Vascular Surgery Center

New Brighton, Minnesota, United States

Dialysis Access Institute

Orangeburg, South Carolina, United States

Spartanburg Regional Health

Spartanburg, South Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 month

Data from ClinicalTrials.gov

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