Trials / Active Not Recruiting
Active Not RecruitingNCT04540302
The Merit WRAPSODY AV Access Efficacy Study (WAVE)
Prospective, Randomized, Controlled, Multicenter Study Comparing the Merit WRAPSODY™ Endovascular Stent Graft to Percutaneous Transluminal Angioplasty for Treatment of Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients. The WAVE Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 357 (estimated)
- Sponsor
- Merit Medical Systems, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Merit WRAPSODY Endovascular Stent Graft | Target lesion treated with stent graft placement |
| DEVICE | PTA | Target lesion treated with standard percutaneous transluminal angioplasty (PTA) |
Timeline
- Start date
- 2021-03-09
- Primary completion
- 2024-02-22
- Completion
- 2026-01-01
- First posted
- 2020-09-07
- Last updated
- 2025-04-13
Locations
43 sites across 4 countries: United States, Brazil, Canada, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04540302. Inclusion in this directory is not an endorsement.