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Using WRAPSODY Endoprosthesis to treat venous stenosis or occlusion in dialysis patients

Prospective, Multicenter, Observational Study to Evaluate the Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion Within the Dialysis Outflow Circuit of an Arteriovenous (AVF) Fistula or AV Graft (AVG) (The WRAP Registry)

Observational Merit Medical Systems, Inc. · NCT05062291

This study is testing a new device to see if it can help dialysis patients with blocked or narrowed blood vessels feel better and improve their treatment.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorMerit Medical Systems, Inc. Industry-sponsored
Locations40 sites (Clayton and 39 other locations)
Trial IDNCT05062291 on ClinicalTrials.gov

What this trial studies

The WRAP Study is a prospective, multicenter, observational study designed to evaluate the safety and efficacy of the Merit WRAPSODY™ Endoprosthesis System in treating stenosis or occlusion within the dialysis outflow circuit of arteriovenous (AV) fistulas or grafts. Participants will be monitored over a 24-month period to gather real-world data on the device's performance. The study aims to enhance understanding of the device's impact on patients undergoing chronic hemodialysis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are undergoing chronic hemodialysis and have a mature AV fistula or graft with stenosis or occlusion.

Not a fit: Patients with planned surgical revisions of their access site or those with infections or coagulation disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options for patients with venous stenosis or occlusion, potentially enhancing their quality of life and dialysis outcomes.

How similar studies have performed: Other studies have shown promise in using endovascular stent grafts for similar conditions, suggesting a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 24 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 of an arteriovenous (AV) fistula or AV graft and is treated with WRAPSODY Endoprosthesis System 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 titanium alloy.
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 Percutaneous Transluminal Angioplasty (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.

Where this trial is running

Clayton and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Venous StenosisVenous OcclusionArteriovenous FistulaArteriovenous GraftAV fistulaAV graft
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.