WRAP North America
Start Date
7/31/2025
Completion Date
7/1/2030
Summary
The goal of this observational study is to investigate the safety and efficacy of the WRAPSODY CIE in a real-world North American population. Participants treated with the WRAPSODY CIE device in accordance with the device instructions for use will be followed in accordance with standard of care up to 3-years post-procedure.
Detailed Description
Prospective, multicenter, observational study to evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit (WRAP North America)
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
Conditions
Locations
Trinity Research Group
Dothan, Alabama 36301
United States
AKDHC Phoenix Surgery Center
Phoenix, Arizona 85016
United States
Apex Research of Riverside
Riverside, California 92505
United States
American Access Care of Jacksonville
Jacksonville, Florida 32218
United States
Sarasota Memorial Research Institute
Sarasota, Florida 34239
United States
University of Kentucky
Lexington, Kentucky 40536
United States
American Access Care of Rhode Island
Providence, Rhode Island 02906
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Medical University of South Carolina
Orangeburg, South Carolina 29118
United States
Spartanburg Medical System
Spartanburg, South Carolina 29303
United States
Bluff City Vascular
Memphis, Tennessee 38104
United States
Texas Research Institute
Fort Worth, Texas 76104
United States
Humble Vascular Surgical Center
Humble, Texas 77338
United States
San Antonio Kidney Disease Center
San Antonio, Texas 78216
United States
Sentara Vascular Specialists
Virginia Beach, Virginia 23507
United States
University Health Network
Toronto, Ontario M5G 2C4
Canada