Actively Recruiting
WRAP North America
Led by Merit Medical Systems, Inc. · Updated on 2026-02-23
250
Participants Needed
12
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
WRAP North America
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject provides written informed consent for study participation.
- Subject is male or female, aged 18 years or older at enrollment.
- Subject is willing to follow standard care procedures and attend follow-up visits for 36 months.
- Subject is undergoing chronic hemodialysis using the hemodialysis access targeted for intervention.
- The dialysis access is mature and has been used for at least one hemodialysis session.
- Subject has stenosis or occlusion in the dialysis outflow circuit and is treated with WRAPSODY CIE as per device instructions.
You will not qualify if you...
- Subject has a planned surgical revision of the access site.
- Subject has a known or suspected infection at the hemodialysis access site, systemic infection, or septicemia.
- Subject has an uncorrectable coagulation disorder.
- Subject has known hypersensitivity to nickel or titanium.
- Subject's hemodialysis access is expected to be abandoned within 6 months.
- Subject is scheduled for kidney transplant or peritoneal dialysis within 6 months after the procedure.
- Full expansion of a PTA balloon cannot be achieved during predilatation.
- Device placement would be in the Superior Vena Cava.
- Presence of inflow or outflow lesions that could threaten long-term access patency beyond the target treatment area.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Trinity Research Group
Dothan, Alabama, United States, 36301
Actively Recruiting
2
Sarasota Memorial Research Institute
Sarasota, Florida, United States, 34239
Actively Recruiting
3
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
5
Medical University of South Carolina
Orangeburg, South Carolina, United States, 29118
Actively Recruiting
6
Spartanburg Medical System
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
7
Bluff City Vascular
Memphis, Tennessee, United States, 38104
Actively Recruiting
8
Texas Research Institute
Fort Worth, Texas, United States, 76104
Actively Recruiting
9
Humble Vascular Surgical Center
Humble, Texas, United States, 77338
Actively Recruiting
10
San Antonio Kidney Disease Center
San Antonio, Texas, United States, 78216
Actively Recruiting
11
Sentara Vascular Specialists
Virginia Beach, Virginia, United States, 23507
Actively Recruiting
12
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
I
Irene Coughlin
CONTACT
V
Vicky Brunk, RN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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