Arterial Occlusive Diseases, Arteriovenous Fistula, Arteriovenous Graft, Fistula
Conditions
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.
Interventions
DEVICEFLEX 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
VentureMed Group Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed