NCT06807099

WRAP North America

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Merit Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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)

Conditions

• Venous Stenosis
• Venous Occlusion

Interventions

Type	Name	Description
DEVICE	Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)	Target Lesion treated with WRAPSODY CIE

Timeline

• Start date: 2025-07-31
• Primary completion: 2027-12-01
• Completion: 2030-07-01
• First posted: 2025-02-04
• Last updated: 2026-02-23

Locations

12 sites across 2 countries: United States, Canada