The Merit WRAPSODY AV Access Efficacy Study (WAVE)

Completed · Not applicable

Conditions studied: Venous Stenosis, Venous Occlusion

In brief

The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit

Key facts

Study ID

NCT04540302

Run by

Merit Medical Systems, Inc.

People needed

357

Starts

2021-03-09

Expected to finish

2025-07-25

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject provides written informed consent
• Subject is male or female, with an age ≥ 18 years at date of enrollment.
• Subject is willing to undergo all follow-up assessments.
• Subject has a life expectancy ≥ 12 months.
• Subject is undergoing chronic hemodialysis.
• Subject has either a mature AVF or AVG in the arm.
• Target lesion(s) involves a de novo stenotic or non-stented restenotic lesion.
• Target lesion has ≥50% stenosis.
• Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm

You may not qualify if…

• Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
• Subject has a stroke diagnosis within 3 months prior to enrollment.
• Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
• Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.
• Target lesion is located within a stent / stent graft.

Where it is running

• Southwest Kidney institute (SKI) Vascular Center — Tempe, Arizona, United States
• Pima Heart and Vascular — Tucson, Arizona, United States
• St. Joseph Hospital — Orange, California, United States
• Vascular Care Connecticut — Darien, Connecticut, United States
• Nephrology Associates — Newark, Delaware, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Open Access Miami, LLC — Miami, Florida, United States
• Leesburg Vascular Access Center & Discovery Medical Research — Oscala, Florida, United States
• Coastal Vascular and Interventional — Pensacola, Florida, United States
• Chicago Access Center — Chicago, Illinois, United States
• Northwestern Medical Center — Chicago, Illinois, United States
• Indiana University Hospital and Methodist Hospital — Indianapolis, Indiana, United States
• King's Daughters Medical Center — Ashland, Kentucky, United States
• Brigham and Women's Faulkner Hospital — West Roxbury, Massachusetts, United States
• Michigan Vascular Access Center — Flint, Michigan, United States
• Vascular Institute of Atlantic Medical Imaging — Vineland, New Jersey, United States
• UNC Health — Chapel Hill, North Carolina, United States
• Charlotte Radiology — Charlotte, North Carolina, United States
• NC Heart and Vascular Research — Raleigh, North Carolina, United States
• North Carolina Nephrology Raleigh Access — Raleigh, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University Pittsburg Medical Center — Pittsburgh, Pennsylvania, United States
• Providence Access Center — Providence, Rhode Island, United States
• Prisma Health System Upstate — Greenville, South Carolina, United States
• Soltero Cardiovascular Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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