WRAP North America

Launched by MERIT MEDICAL SYSTEMS, INC. · Jan 29, 2025

Keywords

ClinConnect Summary

The WRAP North America clinical trial is studying a device called WRAPSODY CIE to see how safe and effective it is for patients with issues in their hemodialysis access, specifically conditions known as venous stenosis (narrowing) and venous occlusion (blockage). This trial will follow participants for up to three years after they receive treatment with the device to gather real-world information about its performance.

To be eligible for this study, participants must be at least 18 years old and currently undergoing chronic hemodialysis. They need to have a mature access site that has been used for treatment and have issues with their dialysis access that the WRAPSODY CIE can help fix. Participants will need to agree to follow-up visits over the three years to monitor their progress. It's important to note that individuals with certain conditions, like infections at the access site or planned surgeries, won't be able to participate. Overall, this study aims to provide valuable insights into how this device works in everyday settings for patients who rely on hemodialysis.

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 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.