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)
Study Type
OBSERVATIONAL
Enrollment
250
Target Lesion treated with WRAPSODY CIE
Medical University of South Carolina
Orangeburg, South Carolina, United States
RECRUITINGBluff City Vascular
Memphis, Tennessee, United States
RECRUITINGTexas Research Institute
Fort Worth, Texas, United States
RECRUITINGProportion 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
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University Health Network
Toronto, Ontario, Canada
RECRUITINGTime frame: Index procedure, 30 days, 6, 12, 24 and 36 months