NCT05062291

Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)

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)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Merit Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population.

Detailed description

Prospective, multicenter, observational study to evaluate the Merit WRAPSODY™ Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft (The WRAP Registry)

Conditions

• Venous Stenosis
• Venous Occlusion

Interventions

Type	Name	Description
DEVICE	Merit WRAPSODY Endovascular Stent Graft	Target Lesion Primary Patency (TLPP)

Timeline

• Start date: 2022-06-23
• Primary completion: 2026-04-15
• Completion: 2027-10-15
• First posted: 2021-09-30
• Last updated: 2025-12-10

Locations

35 sites across 9 countries: Australia, Brazil, Germany, Greece, Israel, Netherlands, New Zealand, Portugal, United Kingdom