WRAP North America

Recruiting now

Conditions studied: Venous Stenosis, Venous Occlusion

In brief

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.

Key facts

Study ID

NCT06807099

Run by

Merit Medical Systems, Inc.

People needed

250

Starts

2025-07-31

Expected to finish

2030-07-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject provides written informed consent for study participation.
• Subject is male or female, with an age ≥ 18 years at date of enrollment.
• Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 36 months.
• Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon.
• The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session.
• 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…

• Subject has a planned surgical revision of access site.
• Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
• Subject has an uncorrectable coagulation disorder.
• Known hypersensitivity to nickel or titanium.
• Subject's hemodialysis access is anticipated to be abandoned within 6 months.
• Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure.
• Full expansion of a PTA balloon cannot be achieved during predilatation.
• Device would be placed in the Superior Vena Cava
• Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.

Where it is running

• Trinity Research Group — Dothan, Alabama, United States (enrolling)
• AKDHC Phoenix Surgery Center — Phoenix, Arizona, United States (enrolling)
• Apex Research of Riverside — Riverside, California, United States (enrolling)
• American Access Care of Jacksonville — Jacksonville, Florida, United States (enrolling)
• Sarasota Memorial Research Institute — Sarasota, Florida, United States (enrolling)
• University of Kentucky — Lexington, Kentucky, United States (enrolling)
• American Access Care of Rhode Island — Providence, Rhode Island, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Medical University of South Carolina — Orangeburg, South Carolina, United States (enrolling)
• Spartanburg Medical System — Spartanburg, South Carolina, United States (enrolling)
• Bluff City Vascular — Memphis, Tennessee, United States (enrolling)
• Texas Research Institute — Fort Worth, Texas, United States (enrolling)
• Humble Vascular Surgical Center — Humble, Texas, United States (enrolling)
• San Antonio Kidney Disease Center — San Antonio, Texas, United States (enrolling)
• Sentara Vascular Specialists — Virginia Beach, Virginia, United States (enrolling)
• University Health Network — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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