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
Qualifiers
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 design
Treatments tested in this trial
- Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
Treatment groups
No treatment groups listed
Locations
16Canada
University Health NetworkM5G 2C4, TorontoOntario, Canada
United States
Alabama
Trinity Research Group36301, Dothan United States
Arizona
AKDHC Phoenix Surgery Center85016, Phoenix United States
California
Apex Research of Riverside92505, Riverside United States
Sponsors and collaborators
Merit Medical Systems, Inc.
Lead sponsor
Source ClinicalTrials.gov