RecruitingNCT06807099

WRAP North America

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)

Sponsor

Merit Medical Systems, Inc.

Enrollment

250 participants

Start Date

Jul 31, 2025

Study Type

OBSERVATIONAL

Conditions

Venous Stenosis Venous Occlusion

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE) for people with venous occlusion and venous stenosis. The study is currently recruiting participants at 16 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMerit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)

Target Lesion treated with WRAPSODY CIE

Locations(16)

Trinity Research Group

Dothan, Alabama, United States

AKDHC Phoenix Surgery Center

Phoenix, Arizona, United States

Apex Research of Riverside

Riverside, California, United States

American Access Care of Jacksonville

Jacksonville, Florida, United States

Sarasota Memorial Research Institute

Sarasota, Florida, United States

University of Kentucky

Lexington, Kentucky, United States

American Access Care of Rhode Island

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Medical University of South Carolina

Orangeburg, South Carolina, United States

Spartanburg Medical System

Spartanburg, South Carolina, United States

Bluff City Vascular

Memphis, Tennessee, United States

Texas Research Institute

Fort Worth, Texas, United States

Humble Vascular Surgical Center

Humble, Texas, United States

Sentara Vascular Specialists

Virginia Beach, Virginia, United States

University Health Network

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT06807099

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