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

Launched by MERIT MEDICAL SYSTEMS, INC. · Sep 21, 2021

Keywords

ClinConnect Summary

The WRAP Study is investigating a new device called the WRAPSODY Endoprosthesis System, which is designed to help treat problems with blood flow in patients who are on chronic hemodialysis. Specifically, it aims to find out how safe and effective this device is for people who have blockages or narrowing in the veins used for dialysis. This study is currently recruiting participants aged 18 and older who have been using a mature hemodialysis access, such as an arteriovenous (AV) fistula or graft, for their treatments.

To participate in this study, individuals must provide consent and agree to follow-up visits for two years. They should be undergoing regular hemodialysis and have a specific blockage in their dialysis access that can be treated with the WRAPSODY device. However, there are certain conditions that would exclude someone from joining, such as having an active infection at the access site or if they are planning to abandon their dialysis access within six months. Participants can expect close monitoring and support throughout the study period to ensure their safety and to gather important information about the treatment's effectiveness.

Gender

ALL

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 24 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 of an arteriovenous (AV) fistula or AV graft and is treated with WRAPSODY Endoprosthesis System 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 titanium alloy.
• • 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 Percutaneous Transluminal Angioplasty (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.