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The Merit WRAPSODY AV Access Efficacy Study (WAVE)
Sponsor: Merit Medical Systems, Inc.
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
Conditions
Interventions
Merit WRAPSODY Endovascular Stent Graft
Target lesion treated with stent graft placement
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