CompletedNot Applicable

FLEX FIRST Registry Research Protocol

United States130 participantsStarted 2022-11-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. 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.

What they're measuring

Target Lesion Primary Patency Rate

Timeframe: 6 months post procedure

Serious Adverse Event Rate

Timeframe: 1 month

Trial details

NCT IDNCT05616104

SponsorVentureMed Group Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02-01

View on ClinicalTrials.gov More Arteriovenous Fistula trials