A prospective, multi-center, randomized observational post-market study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) vs PTA alone for the treatment of obstructive lesions in the native arteriovenous dialysis fistulae.
This is a prospective randomized (1:1) post-market observational study evaluating the FLEX Vessel Prep System followed with PTA vs PTA alone for the treatment of de novo or non-stented restenotic obstructive lesions up to 100 mm in length located in the arteriovenous dialysis fistulae in an upper extremity. The objective is to evaluate and compare the serious adverse event rate at 30 days and primary patency at 6 months when using FLEX Vessel Prep System prior to PTA vs. PTA alone for treatment of obstructive lesion of native arteriovenous fistulae in the upper extremity. Enrollment will continue until complete data sets are collected for up to 75 subjects from up to 7 sites in the US.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
The FLEX Vessel Prep System™ is an over-the-wire sheathed catheter with a three-strut treatment element near the distal tip. As the device is pulled back in a retrograde fashion through the target lesion, the Treatment Element "flexes" providing continuous engagement along the lesion to create controlled depth micro-incisions.
The brand and type of PTA balloon(s) used will be at the discretion of the treating physician and used according to its Instructions for Use (IFU). PTA balloons consist of an over-the-wire catheter with a balloon fixed at the distal tip. Within the lesion the balloon is inflated to a pressure that allows full effacement.
AKDHC Medical Research Services
Phoenix, Arizona, United States
Open Access Vascular Access
Miami, Florida, United States
Minneapolis Vascular Surgery Center
New Brighton, Minnesota, United States
Metrolina Nephrology Associates
Charlotte, North Carolina, United States
Primary Safety Endpoint: Serious Adverse Event Rate
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit through 30 days post- procedure.
Time frame: 30 Days
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North Carolina Nephrology
Raleigh, North Carolina, United States
Dialysis Access Institute
Orangeburg, South Carolina, United States
Dallas Nephrology Associates
Dallas, Texas, United States