FLEX FIRST Registry Research Protocol

Active, not recruiting

• Conditions: Arteriovenous Fistula; Fistula; Arteriovenous Graft; Arterial Occlusive Diseases
• Interventions: Device: FLEX Vessel Prep System

• Registration Number: NCT05616104
• Lead Sponsor: VentureMed Group Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-15
• Study Start: 2022-11-29
• Primary Completion: 2025-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FLEX Vessel Prep followed by angioplasty	FLEX Vessel Prep System	Eligible subjects will be treated with the FLEX Vessel Prep system followed by balloon angioplasty.

Primary Outcome Measures

Name	Time	Method
Target Lesion Primary Patency Rate	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	1 month	Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 1-month post-procedure.

Trial Locations

Locations (4)

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

Open Access Vascular Access; 🇺🇸 Miami, Florida, United States