FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)

NACompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

September 2, 2021

Primary Completion Date

December 1, 2022

Study Completion Date

December 1, 2022

Conditions
Arteriovenous Fistula Stenosis
Interventions
DEVICE

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."

DEVICE

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.

Trial Locations (7)

27610

North Carolina Nephrology, Raleigh

28208

Metrolina Nephrology Associates, Charlotte

29118

Dialysis Access Institute, Orangeburg

33169

Open Access Vascular Access, Miami

55112

Minneapolis Vascular Surgery Center, New Brighton

75235

Dallas Nephrology Associates, Dallas

85012

AKDHC Medical Research Services, Phoenix

All Listed Sponsors
lead

VentureMed Group Inc.

INDUSTRY

NCT05034939 - FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF) | Biotech Hunter | Biotech Hunter