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FLEX FIRST Registry Research Protocol

NCT05616104 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2025-08-07

No results posted yet for this study

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

Interventions

DEVICE

FLEX Vessel Prep System

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.

Sponsors & Collaborators

  • VentureMed Group Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-29
Primary Completion
2025-02-01
Completion
2025-08-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05616104 on ClinicalTrials.gov