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ACTIVE NOT RECRUITING
NCT04540302
NA

The Merit WRAPSODY AV Access Efficacy Study (WAVE)

Sponsor: Merit Medical Systems, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: Prospective, Randomized, Controlled, Multicenter Study Comparing the Merit WRAPSODY™ Endovascular Stent Graft to Percutaneous Transluminal Angioplasty for Treatment of Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients. The WAVE Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

357

Start Date

2021-03-09

Completion Date

2026-01

Last Updated

2025-04-13

Healthy Volunteers

No

Interventions

DEVICE

Merit WRAPSODY Endovascular Stent Graft

Target lesion treated with stent graft placement

DEVICE

PTA

Target lesion treated with standard percutaneous transluminal angioplasty (PTA)

Locations (43)

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

Renal Disease Research Institute

Dallas, Texas, United States

PPG Health PA, DBA-Tarrant Vascular

Fort Worth, Texas, United States

Global Kidney Associates

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Texas Health - Memorial Hermann Katy Hospital

Katy, Texas, United States

CDVA

Pasadena, Texas, United States

Dallas Nephrology Associates

Plano, Texas, United States

Sentara Vascular Specialists

Virginia Beach, Virginia, United States

Instituto Santa Marta De Ensino E Pesquisa

Brasília, Brazil

Real Hospital Português de Beneficência em Pernambuco

Recife, Brazil

Hospital Universitário Pedro Ernesto

Rio de Janeiro, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Toronto General Hospital

Toronto, Canada

Queen Elizabeth Hospital

Birmingham, United Kingdom

Dorset County Hospital

Dorchester, United Kingdom

Royal London Hospital

London, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Lister Hospital

Stevenage, United Kingdom