The Merit WRAPSODY AV Access Efficacy Study (WAVE)
- Conditions
- Venous OcclusionVenous Stenosis
- Interventions
- Device: PTADevice: Merit WRAPSODY Endovascular Stent Graft
- Registration Number
- NCT04540302
- Lead Sponsor
- Merit Medical Systems, Inc.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 357
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AVF Peripheral control group PTA Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA) AVF Peripheral study treatment group Merit WRAPSODY Endovascular Stent Graft Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft AVG Anastomosis Merit WRAPSODY Endovascular Stent Graft All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
- Primary Outcome Measures
Name Time Method Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint) 30 days Proportion of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:) 6 months Proportion of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
- Secondary Outcome Measures
Name Time Method Rates of procedure- and device-related adverse events involving the access circuit Index procedure, 30 days, and months 6, 12 and 24. Proportion of subjects with Target Lesion Primary Patency 12 and 24 months Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP) 6, 12 and 24 months Proportion of subjects with Access Circuit Primary Patency (ACPP) 6, 12 and 24 months Proportion of subjects with Post-Procedure Secondary Patency 6, 12 and 24 months
Trial Locations
- 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