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NCT04540302 · ClinicalTrials.gov registry record · NA
The Merit WRAPSODY AV Access Efficacy Study (WAVE)
A NA study of Venous Occlusion and Venous Stenosis, sponsored by Merit Medical Systems.
- Active
- Registry status
- NA
- Development phase
- 357
- Enrollment target
- 20
- Study locations
NCT04540302: Active NA study of Venous Occlusion and Venous Stenosis, sponsored by Merit Medical Systems.
NCT04540302 is a NA study of Venous Occlusion and Venous Stenosis that is active but no longer recruiting, run by Merit Medical Systems. The registered enrollment target is 357 participants, above the 139-participant average among 4 other Venous Occlusion trials with a reported enrollment target (157% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04540302, a NA study of Venous Occlusion and Venous Stenosis, is active but no longer recruiting, sponsored by Merit Medical Systems.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 357 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
Percentage of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.
Conditions Studied
Interventions
- DEVICE PTA
- DEVICE Merit WRAPSODY Endovascular Stent Graft
Study Locations (20)
Florida
- First Coast Cardiovascular Institute - Jacksonville
- Open Access Miami, LLC - Miami
- Leesburg Vascular Access Center & Discovery Medical Research - Oscala
- Coastal Vascular and Interventional - Pensacola
North Carolina
- UNC Health - Chapel Hill
- Charlotte Radiology - Charlotte
- NC Heart and Vascular Research - Raleigh
- North Carolina Nephrology Raleigh Access - Raleigh
Arizona
- Southwest Kidney institute (SKI) Vascular Center - Tempe
- Pima Heart and Vascular - Tucson
Illinois
- Chicago Access Center - Chicago
- Northwestern Medical Center - Chicago
California
- St. Joseph Hospital - Orange
Connecticut
- Vascular Care Connecticut - Darien
Delaware
- Nephrology Associates - Newark
Indiana
- Indiana University Hospital and Methodist Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2021-03-09 |
| Est. Completion | 2026-01 |
| Phase | NA |
What the registry record for NCT04540302 still lists
NCT04540302 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, above the 139-participant average among 4 other Venous Occlusion trials with a reported enrollment target (157% higher).
The record links to 2 conditions, with Venous Occlusion appearing as the primary indexed condition, and to 2 interventions - of which PTA is the first listed.
NCT04540302 names 20 study sites across 12 states, led by Florida, North Carolina, Arizona.
Frequently Asked Questions
What is clinical trial NCT04540302 about?
NCT04540302 is a clinical study titled "The Merit WRAPSODY AV Access Efficacy Study (WAVE)". 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
What is the current status of trial NCT04540302?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 357 participants. The study started on 2021-03-09. Estimated completion is 2026-01.
What conditions does trial NCT04540302 study?
This clinical trial studies the following conditions: Venous Occlusion, Venous Stenosis.
What interventions are being tested in trial NCT04540302?
The interventions under investigation include: PTA (DEVICE), Merit WRAPSODY Endovascular Stent Graft (DEVICE).
Who is sponsoring clinical trial NCT04540302?
This trial is sponsored by Merit Medical Systems, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04540302 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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