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
Status: Active_not_recruiting
Location: See all (43) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Southwest Kidney institute (SKI) Vascular Center
Tempe
Pima Heart and Vascular
Tucson
California
St. Joseph Hospital
Orange
Connecticut
Vascular Care Connecticut
Darien
Delaware
Nephrology Associates
Newark
Florida
First Coast Cardiovascular Institute
Jacksonville
Open Access Miami, LLC
Miami
Leesburg Vascular Access Center & Discovery Medical Research
Ocala
Coastal Vascular and Interventional
Pensacola
Illinois
Chicago Access Center
Chicago
Northwestern Medical Center
Chicago
Indiana
Indiana University Hospital and Methodist Hospital
Indianapolis
Kentucky
King's Daughters Medical Center
Ashland
Massachusetts
Brigham and Women's Faulkner Hospital
West Roxbury
Michigan
Michigan Vascular Access Center
Flint
North Carolina
UNC Health
Chapel Hill
Charlotte Radiology
Charlotte
NC Heart and Vascular Research
Raleigh
North Carolina Nephrology Raleigh Access
Raleigh
New Jersey
Vascular Institute of Atlantic Medical Imaging
Vineland
Ohio
Cleveland Clinic
Cleveland
Pennsylvania
University Pittsburg Medical Center
Pittsburgh
Rhode Island
Providence Access Center
Providence
South Carolina
Prisma Health System Upstate
Greenville
Texas
Renal Disease Research Institute
Dallas
Soltero Cardiovascular Research Center
Dallas
PPG Health PA, DBA-Tarrant Vascular
Fort Worth
Global Kidney Associates
Houston
Houston Methodist Hospital
Houston
University of Texas Health - Memorial Hermann Katy Hospital
Katy
CDVA
Pasadena
Dallas Nephrology Associates
Plano
Virginia
Sentara Vascular Specialists
Virginia Beach
Other Locations
Brazil
Instituto Santa Marta De Ensino E Pesquisa
Brasília
Real Hospital Português de Beneficência em Pernambuco
Recife
Hospital Universitário Pedro Ernesto
Rio De Janeiro
Instituto Dante Pazzanese de Cardiologia
São Paulo
Canada
Toronto General Hospital
Toronto
United Kingdom
Queen Elizabeth Hospital
Birmingham
Dorset County Hospital
Dorchester
Royal London Hospital
London
Churchill Hospital
Oxford
Lister Hospital
Stevenage
Time Frame
Start Date: 2021-03-09
Completion Date: 2026-01
Participants
Target number of participants: 357
Treatments
Experimental: AVF Peripheral study treatment group
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Other: AVF Peripheral control group
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
Experimental: AVG Anastomosis
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Authors
Jeffery Hull, Theodore Saad, Neghae Mawla, Fernando Kafie, Vivek Veerapaneni, Saravanan Balamuthusamy, Paul Gagne, Kristofer Charlton-Ouw, Stephen Hohmann, Karl Illig, Sanford Altman, Angelo Makris, Thomas Casciani, Mohamed Sheta, Micah Watts, Jonah Licht, Dirk Hentschel, Eric Peden, Jeffrey Hoggard, Robert Beasley, Stuart Harlin, Randy Cooper, Mark Lessne, Michael Lichtenberg, Kate Steiner, Theodore Yuo, Scott Berman, Haimanot Wasse, Yazan Khatib, Scott Resnick, Bhavraj Khalsa, John Aruny, Jeffrey Siegel, Robert Molnar, Ounali Jaffer, Martin Krauss, Thomas Zeller
Related Therapeutic Areas
Sponsors
Leads: Merit Medical Systems, Inc.