WRAP North America: use of the WRAPSODY endoprosthesis for dialysis access outflow blockages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Trinity Research Group
  Dothan, Alabama, United States Recruiting
• AKDHC Phoenix Surgery Center
  Phoenix, Arizona, United States Recruiting
• Apex Research of Riverside
  Riverside, California, United States Recruiting
• American Access Care of Jacksonville
  Jacksonville, Florida, United States Recruiting
• Sarasota Memorial Research Institute
  Sarasota, Florida, United States Recruiting
• University of Kentucky
  Lexington, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Irene Coughlin
• Email: irene.coughlin@merit.com
• Phone: +1-385-766-9133

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GORE VIABAHN FORTEGRA Venous Stent Post-Approval Study

  This study tests the GORE VIABAHN FORTEGRA Venous Stent in real-world patients with venous diseases to see how it performs after it is approved.

  Recruiting at 4 sites W.L.Gore & Associates · Darien, Connecticut and 3 other locations · NCT07538609

• Using Solaris DE Endoprosthesis to treat AV access stenosis or occlusion

  This study is testing if the Solaris DE Endoprosthesis can provide better treatment for patients with blocked or narrowed blood vessels in their dialysis access compared to the standard method.

  Recruiting at 5 sites Scitech Produtos Medicos SA · Salvador, Estado de Bahia and 4 other locations · NCT06096142

• Noninvasive Imaging of Intracranial Venous Sinus Stents with Ultra-High-Resolution Photon-Counting CT Angiography

  This study tests whether ultra-high-resolution photon-counting CT angiography can better visualize intracranial venous sinus stents and reduce metal-related artifacts in adults who have had stents.

  Recruiting Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07762677

• BosSTENT implantation for pulse-synchronous tinnitus from venous sinus narrowing

  This trial will try a new stent called BosSTENT to reduce severe pulse-synchronous tinnitus in adults whose symptoms are caused by narrowing of the cerebral venous sinus and improve when the jugular vein is compressed.

  Recruiting at 5 sites Sonorous NV, Inc · Ottawa, Canada and 5 other locations · NCT07070089

• Comparing stent implantation to medical therapy for idiopathic intracranial hypertension

  This study is testing whether putting in a stent helps people with idiopathic intracranial hypertension feel better compared to just using medication.

  Recruiting Phase 3 Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT05707442

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.