Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT04540302
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-13
First Post:
2020-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Merit WRAPSODY AV Access Efficacy Study (WAVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'New Zealand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study comprises 2 independent cohorts:\n\n1. Up to 244 AVF Peripheral Subjects (1:1 randomization, with approximately 122 in the study treatment and control groups)\n2. Up to 113 AVG Anastomosis Subjects (no randomization, comparison to Performance Goals)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 357}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)', 'timeFrame': '30 days', 'description': '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.'}, {'measure': 'Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)', 'timeFrame': '6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with Target Lesion Primary Patency', 'timeFrame': '12 and 24 months'}, {'measure': 'Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Proportion of subjects with Access Circuit Primary Patency (ACPP)', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Proportion of subjects with Post-Procedure Secondary Patency', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Rates of procedure- and device-related adverse events involving the access circuit', 'timeFrame': 'Index procedure, 30 days, and months 6, 12 and 24.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['AVF', 'AVG', 'AV fistula', 'AV graft'], 'conditions': ['Venous Stenosis', 'Venous Occlusion']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject provides written informed consent\n* Subject is male or female, with an age ≥ 18 years at date of enrollment.\n* Subject is willing to undergo all follow-up assessments.\n* Subject has a life expectancy ≥ 12 months.\n* Subject is undergoing chronic hemodialysis.\n* Subject has either a mature AVF or AVG in the arm.\n* Target lesion(s) involves a de novo stenotic or non-stented restenotic lesion.\n* Target lesion has ≥50% stenosis.\n* Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm\n\nExclusion Criteria:\n\n* Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.\n* Subject has a stroke diagnosis within 3 months prior to enrollment.\n* Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.\n* Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.\n* Target lesion is located within a stent / stent graft.'}, 'identificationModule': {'nctId': 'NCT04540302', 'acronym': 'WAVE', 'briefTitle': 'The Merit WRAPSODY AV Access Efficacy Study (WAVE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merit Medical Systems, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CVO-P3-20-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AVF Peripheral study treatment group', 'description': 'Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft', 'interventionNames': ['Device: Merit WRAPSODY Endovascular Stent Graft']}, {'type': 'OTHER', 'label': 'AVF Peripheral control group', 'description': 'Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)', 'interventionNames': ['Device: PTA']}, {'type': 'EXPERIMENTAL', 'label': 'AVG Anastomosis', 'description': 'All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft', 'interventionNames': ['Device: Merit WRAPSODY Endovascular Stent Graft']}], 'interventions': [{'name': 'Merit WRAPSODY Endovascular Stent Graft', 'type': 'DEVICE', 'description': 'Target lesion treated with stent graft placement', 'armGroupLabels': ['AVF Peripheral study treatment group', 'AVG Anastomosis']}, {'name': 'PTA', 'type': 'DEVICE', 'description': 'Target lesion treated with standard percutaneous transluminal angioplasty (PTA)', 'armGroupLabels': ['AVF Peripheral control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85281', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest Kidney institute (SKI) Vascular Center', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '85718', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pima Heart and Vascular', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Hospital', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '06820', 'city': 'Darien', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Vascular Care Connecticut', 'geoPoint': {'lat': 41.07871, 'lon': -73.46929}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Nephrology Associates', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'First Coast Cardiovascular Institute', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Open Access Miami, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34471', 'city': 'Oscala', 'state': 'Florida', 'country': 'United States', 'facility': 'Leesburg Vascular Access Center & Discovery Medical Research'}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Vascular and Interventional', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '60559', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Access Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Hospital and Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '41101', 'city': 'Ashland', 'state': 'Kentucky', 'country': 'United States', 'facility': "King's Daughters Medical Center", 'geoPoint': {'lat': 38.47841, 'lon': -82.63794}}, {'zip': '02130', 'city': 'West Roxbury', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Faulkner Hospital", 'geoPoint': {'lat': 42.27926, 'lon': -71.1495}}, {'zip': '48507', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Vascular Access Center', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '80360', 'city': 'Vineland', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Vascular Institute of Atlantic Medical Imaging', 'geoPoint': {'lat': 39.48623, 'lon': -75.02573}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Health', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28202', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Radiology', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'NC Heart and Vascular Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27610', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Nephrology Raleigh Access', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University Pittsburg Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Providence Access Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health System Upstate', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '75226', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Soltero Cardiovascular Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Renal Disease Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'PPG Health PA, DBA-Tarrant Vascular', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Global Kidney Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77494', 'city': 'Katy', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health - Memorial Hermann Katy Hospital', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '77504', 'city': 'Pasadena', 'state': 'Texas', 'country': 'United States', 'facility': 'CDVA', 'geoPoint': {'lat': 29.69106, 'lon': -95.2091}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Nephrology Associates', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '23507', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Vascular Specialists', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'city': 'Brasília', 'country': 'Brazil', 'facility': 'Instituto Santa Marta De Ensino E Pesquisa', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'city': 'Recife', 'country': 'Brazil', 'facility': 'Real Hospital Português de Beneficência em Pernambuco', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Universitário Pedro Ernesto', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Dante Pazzanese de Cardiologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Toronto', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Dorchester', 'country': 'United Kingdom', 'facility': 'Dorset County Hospital', 'geoPoint': {'lat': 50.71667, 'lon': -2.43333}}, {'zip': 'E1 1FR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'SG1 4AB', 'city': 'Stevenage', 'country': 'United Kingdom', 'facility': 'Lister Hospital', 'geoPoint': {'lat': 51.90224, 'lon': -0.20256}}], 'overallOfficials': [{'name': 'Mahmood K Razavi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Joseph's Hospital, Orange, CA"}, {'name': 'Robert Jones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Queen Elizabeth Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merit Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}