RecruitingNot Applicable

WRAP North America

United States, Canada250 participantsStarted 2025-07-31

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)

Timeframe: 6 months

Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)

Timeframe: 30 days

Trial details

NCT IDNCT06807099

SponsorMerit Medical Systems, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Irene Coughlin

+1-385-766-9133 irene.coughlin@merit.com

View on ClinicalTrials.gov More Venous Stenosis trials