This is a prospective, multi- center, randomized (1:1) clinical study evaluating the FLEX Vessel Prep System followed with PTA (TEST arm) vs PTA alone (CONTROL arm) 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.
A prospective, multi-center, randomized (1:1) clinical study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) (study arm) vs PTA alone (control arm) for the treatment of obstructive lesions in the native arteriovenous dialysis fistulae.