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
Sponsors and collaborators
Source ClinicalTrials.gov