An observational study in Venous Stenosis and Venous Occlusion, sponsored by Merit Medical Systems, Inc.. Recruiting at 16 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Merit Medical Systems, Inc. · Observational
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.
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)
247 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.
This study's planned enrollment of 250 is above the median of 100 across 70 observational studies indexed under Arteriovenous Fistula.
Browse Arteriovenous Fistula studies →Merit Medical Systems, Inc. is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with stenosis or occlusion within the dialysis outflow circuit who meet the inclusion and exclusion criteria are intended to participate in this study. The eligibility criteria are kept to a minimum to better represent the subject profile treated in actual clinical practice without selecting sub-groups of particular low/high risk or excluding certain diseases or anatomies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Target Lesion treated with WRAPSODY CIE
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)
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.
Time frame: 6 months
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)
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)
Time frame: 30 days
Proportion of subjects with Target Lesion Primary Patency
Proportion of subjects with Target Lesion Primary Patency at months 12, 24 and 36.
Time frame: 12, 24 and 36 months
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Time frame: 6, 12, 24 and 36 months
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Time frame: 6, 12, 24 and 36 months
Rates of procedure- and device-related adverse events
Number of subjects with procedure- and device-related adverse events
Time frame: Index procedure, 30 days, 6, 12, 24 and 36 months
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
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