RecruitingVenous StenosisVenous Occlusion

WRAP North America

Eligible age

18+ yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

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.

Sponsor: Merit Medical Systems, Inc.

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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