FLEX FIRST Registry Research Protocol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arteriovenous Fistula
- Sponsor
- VentureMed Group Inc.
- Enrollment
- 130
- Locations
- 4
- Primary Endpoint
- Target Lesion Primary Patency Rate
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
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:
- •Elevated venous pressure during hemodialysis,
- •Abnormal physical findings, and
- •Unexplained decrease in delivered dialysis dose.
- •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.
Outcomes
Primary Outcomes
Target Lesion Primary Patency Rate
Time Frame: 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
Time Frame: 1 month
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 1-month post-procedure.