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NCT06807099Recruiting

WRAP North America

Merit Medical Systems, Inc.

Start Date

7/31/2025

Completion Date

7/1/2030

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

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)

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Conditions

Venous StenosisVenous Occlusion

Locations

Trinity Research Group

Dothan, Alabama 36301

United States

AKDHC Phoenix Surgery Center

Phoenix, Arizona 85016

United States

Apex Research of Riverside

Riverside, California 92505

United States

American Access Care of Jacksonville

Jacksonville, Florida 32218

United States

Sarasota Memorial Research Institute

Sarasota, Florida 34239

United States

University of Kentucky

Lexington, Kentucky 40536

United States

American Access Care of Rhode Island

Providence, Rhode Island 02906

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Medical University of South Carolina

Orangeburg, South Carolina 29118

United States

Spartanburg Medical System

Spartanburg, South Carolina 29303

United States

Bluff City Vascular

Memphis, Tennessee 38104

United States

Texas Research Institute

Fort Worth, Texas 76104

United States

Humble Vascular Surgical Center

Humble, Texas 77338

United States

San Antonio Kidney Disease Center

San Antonio, Texas 78216

United States

Sentara Vascular Specialists

Virginia Beach, Virginia 23507

United States

University Health Network

Toronto, Ontario M5G 2C4

Canada