Clinical trial NCT06807099: WRAP North America
Official title: 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
Overall status: NOT_YET_RECRUITING
Conditions: Venous Stenosis
Venous Occlusion
Keywords: Arteriovenous Fistula (AVF)
Arteriovenous Graft (AVG)
AV fistula
AV graft
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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.

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

1. Subject provides written informed consent for study participation.
2. Subject is male or female, with an age ≥ 18 years at date of enrollment.
3. Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 36 months.
4. Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon.
5. The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session.
6. 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:

1. Subject has a planned surgical revision of access site.
2. Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
3. Subject has an uncorrectable coagulation disorder.
4. Known hypersensitivity to nickel or titanium.
5. Subject's hemodialysis access is anticipated to be abandoned within 6 months.
6. Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure.
7. Full expansion of a PTA balloon cannot be achieved during predilatation.
8. Device would be placed in the Superior Vena Cava
9. Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.

Primary outcomes:
measure: Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)
timeFrame: 6 months
measure: Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)
timeFrame: 30 days
Secondary outcomes:
measure: Proportion of subjects with Target Lesion Primary Patency
timeFrame: 12, 24 and 36 months
measure: Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
timeFrame: 6, 12, 24 and 36 months
measure: Proportion of subjects with Access Circuit Primary Patency (ACPP)
timeFrame: 6, 12, 24 and 36 months
measure: Rates of procedure- and device-related adverse events
timeFrame: Index procedure, 30 days and 6 months
Other outcomes:
Locations:
Study officials:
References: