NCT05616104

FLEX FIRST Registry Research Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: VentureMed Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Arteriovenous Fistula
• Arteriovenous Graft
• Fistula
• Arterial Occlusive Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-29
• Primary completion: 2025-02-01
• Completion: 2025-08-04
• First posted: 2022-11-15
• Last updated: 2025-08-07

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study