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NCT06807099 · ClinicalTrials.gov registry record
WRAP North America
A clinical trial of Venous Occlusion and Venous Stenosis, sponsored by Merit Medical Systems.
- Recruiting
- Registry status
- 250
- Enrollment target
- 12
- Study locations
NCT06807099: Recruiting study of Venous Occlusion and Venous Stenosis, sponsored by Merit Medical Systems.
NCT06807099 is a study of Venous Occlusion and Venous Stenosis that is actively recruiting participants, run by Merit Medical Systems. The registered enrollment target is 250 participants, above the 166-participant average among 4 other Venous Occlusion trials with a reported enrollment target (51% higher). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06807099, a study of Venous Occlusion and Venous Stenosis, is actively recruiting participants, sponsored by Merit Medical Systems.
- RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 12
- Study locations
Study 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.
Primary Outcome
The proportion of subjects with Target Lesion Primary Patency (TLPP) at 6 months. Target Lesion Primary Patency (TLPP) defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
Conditions Studied
Interventions
- DEVICE Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
Study Locations (12)
South Carolina
- Medical University of South Carolina - Charleston
- Medical University of South Carolina - Orangeburg
- Spartanburg Medical System - Spartanburg
Texas
- Texas Research Institute - Fort Worth
- Humble Vascular Surgical Center - Humble
- San Antonio Kidney Disease Center - San Antonio
Alabama
- Trinity Research Group - Dothan
Florida
- Sarasota Memorial Research Institute - Sarasota
Kentucky
- University of Kentucky - Lexington
Tennessee
- Bluff City Vascular - Memphis
Virginia
- Sentara Vascular Specialists - Virginia Beach
Ontario
- University Health Network - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2025-07-31 |
| Est. Completion | 2030-07 |
What NCT06807099 shows while recruiting
NCT06807099 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 166-participant average among 4 other Venous Occlusion trials with a reported enrollment target (51% higher).
The record links to 2 conditions, with Venous Occlusion appearing as the primary indexed condition, and to 1 intervention - of which Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE) is the first listed.
NCT06807099 lists 12 locations in 8 states (South Carolina, Texas, Alabama).
Frequently Asked Questions
What is clinical trial NCT06807099 about?
NCT06807099 is a clinical study titled "WRAP North America". 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 t...
What is the current status of trial NCT06807099?
This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2025-07-31. Estimated completion is 2030-07.
What conditions does trial NCT06807099 study?
This clinical trial studies the following conditions: Venous Occlusion, Venous Stenosis.
What interventions are being tested in trial NCT06807099?
The interventions under investigation include: Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE) (DEVICE).
Who is sponsoring clinical trial NCT06807099?
This trial is sponsored by Merit Medical Systems, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06807099 being conducted?
This trial has 12 study locations across Alabama, Florida, Kentucky, South Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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