WRAP North America (NCT06807099) | Clinical Trial Compass
RecruitingNot Applicable
WRAP North America
United States250 participantsStarted 2025-07-31
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session.
✓. Subject has stenosis or occlusion within the dialysis outflow circuit and is treated with WRAPSODY CIE in accordance with device instructions for use.
Exclusion criteria
✕. 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.
✕. Subject's hemodialysis access is anticipated to be abandoned within 6 months.
✕. Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure.
What they're measuring
1
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)
Timeframe: 6 months
2
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)