75
Participants
Start Date
September 2, 2021
Primary Completion Date
December 1, 2022
Study Completion Date
December 1, 2022
FLEX Vessel Prep System
"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."
Angioplasty
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.
North Carolina Nephrology, Raleigh
Metrolina Nephrology Associates, Charlotte
Dialysis Access Institute, Orangeburg
Open Access Vascular Access, Miami
Minneapolis Vascular Surgery Center, New Brighton
Dallas Nephrology Associates, Dallas
AKDHC Medical Research Services, Phoenix
VentureMed Group Inc.
INDUSTRY