FLEX FIRST Registry Research Protocol

Study 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.

Official Title
-----------------
FLEX FIRST Registry Research Protocol

Conditions
-----------------
Arteriovenous Fistula, Arteriovenous Graft, Fistula, Arterial Occlusive Diseases

Intervention / Treatment
-----------------
* Device: FLEX Vessel Prep System


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FLEX Vessel Prep followed by angioplasty<br>Eligible subjects will be treated with the FLEX Vessel Prep system followed by balloon angioplasty. | Device: FLEX Vessel Prep System<br>* 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.<br>* Other names: Balloon Angioplasty;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Primary Patency Rate | Defined as freedom from clinically driven target lesion re-intervention (CD-TLR) or access circuit thrombosis measured through 6-months post- procedure. | 6 months post procedure | 
| Serious Adverse Event Rate | Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 1-month post-procedure. | 1 month |