WRAP North America
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMerit Medical Systems, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject provides written informed consent for study participation.
Subject is male or female, with an age ≥ 18 years at date of enrollment.
Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 36 months.
Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon.
Disqualifiers
Subject has a planned surgical revision of access site.
Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
Subject has an uncorrectable coagulation disorder.
Known hypersensitivity to nickel or titanium.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
DeviceTarget Lesion treated with WRAPSODY CIE
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 months2
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 daysSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov