Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
357 participants
INTERVENTIONAL
2021-03-09
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Up to 244 AVF Peripheral Subjects (1:1 randomization, with approximately 122 in the study treatment and control groups)
2. Up to 113 AVG Anastomosis Subjects (no randomization, comparison to Performance Goals)
TREATMENT
NONE
Study Groups
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AVF Peripheral study treatment group
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft
Target lesion treated with stent graft placement
AVF Peripheral control group
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
PTA
Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
AVG Anastomosis
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Merit WRAPSODY Endovascular Stent Graft
Target lesion treated with stent graft placement
Interventions
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Merit WRAPSODY Endovascular Stent Graft
Target lesion treated with stent graft placement
PTA
Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Merit Medical Systems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mahmood K Razavi, MD
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Hospital, Orange, CA
Robert Jones, MD
Role: PRINCIPAL_INVESTIGATOR
The Queen Elizabeth Hospital
Locations
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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
Countries
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Other Identifiers
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CVO-P3-20-01
Identifier Type: -
Identifier Source: org_study_id
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