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WRAP North America

Recruitingn/aAges 18 Years - anyAllMerit Medical Systems, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Subject provides written informed consent for study participation. 2. Subject is male or female, with an age ≥ 18 years at date of enrollment. 3. Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 36 months. 4. Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon. 5. The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session. 6. Subject has stenosis or occlusion within the dialysis outflow circuit and is treated with WRAPSODY CIE in accordance with device instructions for use. Exclusion Criteria: 1. Subject has a planned surgical revision of access site. 2. Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia. 3. Subject has an uncorrectable coagulation disorder. 4. Known hypersensitivity to nickel or titanium. 5. Subject's hemodialysis access is anticipated to be abandoned within 6 months. 6. Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure. 7. Full expansion of a PTA balloon cannot be achieved during predilatation. 8. Device would be placed in the Superior Vena Cava 9. Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.
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What it tests

  • Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
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Where

16 sites
Trinity Research Group
Dothan, United States
AKDHC Phoenix Surgery Center
Phoenix, United States
Apex Research of Riverside
Riverside, United States
American Access Care of Jacksonville
Jacksonville, United States
Sarasota Memorial Research Institute
Sarasota, United States
University of Kentucky
Lexington, United States
American Access Care of Rhode Island
Providence, United States
Medical University of South Carolina
Charleston, United States

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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