NCT03552289 - Cook Enforcer Post-Market Study | Biotech Hunter

Enrollment

211

Participants

Timeline

Start Date

August 7, 2018

Primary Completion Date

May 29, 2019

Study Completion Date

August 27, 2019

Conditions

End-Stage Renal Disease

Interventions

DEVICE

Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula

DEVICE

Conventional angioplasty balloon catheters

Commercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula

Trial Locations (5)

19713

Delaware Kidney/Nephrology Associates, PA, Newark

22193

Vascular Institute of Virginia, Woodbridge

24014

Fairlawn Surgery Center, Roanoke

85012

Arizona Kideny Disease & Hypertension Surgery Center, Phoenix

06820

The Vascular Experts, Darien

All Listed Sponsors

lead

Cook Research Incorporated

INDUSTRY