WRAP North America Study for Venous Stenosis and Occlusion
This study, called WRAP North America, is looking at the safety and effectiveness of a device called the Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE). This device is used to treat narrowing (stenosis) or blockages (occlusion) in veins, specifically in people undergoing chronic hemodialysis. The study aims to see how well the device keeps the treated vein open (Target Lesion Primary Patency) after 6 months, and to track any safety issues within 30 days. You might be able to join if you are 18 or older, are on chronic hemodialysis, and are willing to follow up with the study for up to 3 years. The study is currently unclear on its recruitment status.
- Study design
- This is an observational study with a planned enrollment of 250 participants. It is a prospective, multicenter study.
- What's involved
- You would need to provide written informed consent and be willing to comply with standard care procedures and follow-up visits for up to 36 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 3 years after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
WRAP North America
At a glance
Conditions
Where it's being run
16 sites across 12 statesWho to contact
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What this trial measures
- Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)6 months
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.
- Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)30 days
Proportions of subjects without any localized or systematic safety events through 30 days post-procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including CD-TLR or target lesion thrombosis)