Active — Not RecruitingNot Applicable

Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)

Australia500 participantsStarted 2022-06-23

Plain-language summary

The WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population.

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.

✓. 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 24 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 of an arteriovenous (AV) fistula or AV graft and is treated with WRAPSODY Endoprosthesis System in accordance with device instructions for use.

✕. 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 titanium alloy.
✕. 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.
✕. Full expansion of a Percutaneous Transluminal Angioplasty (PTA) balloon cannot be achieved during predilatation.
✕. Device would be placed in the Superior Vena Cava

Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint)

Timeframe: 6 months

Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)

Timeframe: 30 days

NCT IDNCT05062291

SponsorMerit Medical Systems, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-04-15

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.

✓. 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 24 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 of an arteriovenous (AV) fistula or AV graft and is treated with WRAPSODY Endoprosthesis System in accordance with device instructions for use.

✕. 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 titanium alloy.
✕. 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.
✕. Full expansion of a Percutaneous Transluminal Angioplasty (PTA) balloon cannot be achieved during predilatation.
✕. Device would be placed in the Superior Vena Cava