WRAP North America: use of the WRAPSODY endoprosthesis for dialysis access outflow blockages
Prospective, Multicenter, Observational Study to Evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion Within the Dialysis Outflow Circuit (WRAP North America)
This study will test the WRAPSODY device in adults on chronic hemodialysis who have venous stenosis or occlusion in their dialysis outflow to see if it is safe and keeps access working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merit Medical Systems, Inc. Industry-sponsored |
| Locations | 12 sites (Dothan, Alabama and 11 other locations) |
| Trial ID | NCT06807099 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter, observational registry follows adult hemodialysis patients treated with the Merit WRAPSODY® Cell Impermeable Endoprosthesis for stenosis or occlusion in the dialysis outflow circuit. Enrolled participants receive the device per the instructions for use and are followed according to each site's standard of care for up to three years. The study collects safety data, patency outcomes, and need for reintervention in a real-world North American population. No experimental interventions beyond standard device use and routine follow-up are required.
Who should consider this trial
Good fit: Adults (≥18 years) on chronic hemodialysis with a mature arteriovenous fistula or graft that has been used for dialysis and who have stenosis or occlusion in the outflow circuit treated with WRAPSODY per the device instructions are the intended participants.
Not a fit: Patients with planned surgical revision of the access, active local or systemic infection, uncorrectable coagulation disorders, or known nickel or titanium hypersensitivity, as well as those who are not candidates for an endoprosthesis, are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the WRAPSODY device could help keep dialysis access functioning longer and reduce the need for repeat procedures.
How similar studies have performed: Covered stent-graft devices similar to WRAPSODY have shown improved access patency in prior studies and WRAPSODY has been evaluated before, but large-scale, real-world North American outcome data are still limited.
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 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.
Where this trial is running
Dothan, Alabama and 11 other locations
- Trinity Research Group — Dothan, Alabama, United States (Recruiting)
- Sarasota Memorial Research Institute — Sarasota, Florida, United States (Recruiting)
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Medical University of South Carolina — Orangeburg, South Carolina, United States (Recruiting)
- Spartanburg Medical System — Spartanburg, South Carolina, United States (Recruiting)
- Bluff City Vascular — Memphis, Tennessee, United States (Recruiting)
- Texas Research Institute — Fort Worth, Texas, United States (Recruiting)
- Humble Vascular Surgical Center — Humble, Texas, United States (Recruiting)
- San Antonio Kidney Disease Center — San Antonio, Texas, United States (Recruiting)
- Sentara Vascular Specialists — Virginia Beach, Virginia, United States (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Irene Coughlin
- Email: irene.coughlin@merit.com
- Phone: +1-385-766-9133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.