Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-29 @ 3:12 PM
Study NCT ID:
NCT01033357
Status:
TERMINATED
Last Update Posted:
2013-02-11
First Post:
2009-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006965', 'term': 'Hyperplasia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014180', 'term': 'Transplantation'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'whyStopped': "Imbalance in the # graft infections between the tx's (graft vs. graft + wrap)", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'dispFirstSubmitDate': '2013-02-07', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-07', 'studyFirstSubmitDate': '2009-12-15', 'dispFirstSubmitQcDate': '2013-02-07', 'studyFirstSubmitQcDate': '2009-12-15', 'dispFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dialysis', 'hemodialysis', 'neointimal hyperplasia'], 'conditions': ['End Stage Renal Failure on Dialysis', 'Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the long term use of the experimental Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing hemodialysis access (via an expanded polytetrafluoroethylene (ePTFE) graft).', 'detailedDescription': 'The primary objective of this study is to determine long term safety of the Lifespan® ePTFE Vascular Graft and Vascular Wrap(TM) Paclitaxel-Eluting Mesh in comparison to the Lifespan® graft alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: To be considered for enrollment, subjects must:\n\n* have been randomized in protocol 012-VWAV06;\n* have signed and dated an IRB-approved written informed consent to participate in 012-VWAV06 as well as this study;\n* be willing to comply with all aspects of the evaluation schedule over a period of 60 months post device insertion;\n* allow representatives of the sponsor, designated Clinical Research Organization (CRO), Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records.\n\nExclusion Criteria:\n\n* Subjects who withdrew or were withdrawn from study 012-VWAV06.'}, 'identificationModule': {'nctId': 'NCT01033357', 'briefTitle': 'Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access', 'organization': {'class': 'INDUSTRY', 'fullName': 'Angiotech Pharmaceuticals'}, 'officialTitle': 'A Long Term Safety Study of the Vascular Wrap(TM) Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® Graft in the Upper Extremity for Hemodialysis Vascular Access', 'orgStudyIdInfo': {'id': '014-VWAV07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Graft, Vascular Wrap', 'description': 'Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)', 'interventionNames': ['Device: Graft, Vascular Wrap']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Graft', 'description': 'Lifespan® ePTFE Vascular Graft Only', 'interventionNames': ['Device: Lifespan® ePTFE Vascular Graft Only']}], 'interventions': [{'name': 'Graft, Vascular Wrap', 'type': 'DEVICE', 'otherNames': ['Vascular Wrap'], 'description': 'Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)', 'armGroupLabels': ['Graft, Vascular Wrap']}, {'name': 'Lifespan® ePTFE Vascular Graft Only', 'type': 'DEVICE', 'description': 'Vascular Graft only', 'armGroupLabels': ['Graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Ladenheim, Inc.', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Centinela Hospital', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'National Institute of Clinical Research', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC CVTI - Healthcare Consultation II', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92109', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Medical Group', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VA Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32605', 'city': 'Gainsville', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Research Network, LLC'}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clincal Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Discovery Medical Research Group', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32501', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida- Research Foundation', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31208', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Cardiothoracic and Vascular Surgery Associates', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '61603', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Renal Care Associates', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Washington County Hospital Association', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '48507', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Vascular Research Center', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Thoracic and Cardiovascular Healthcare Foundation', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '11355', 'city': 'Flushing', 'state': 'New York', 'country': 'United States', 'facility': 'Nephrology Associates P. C.', 'geoPoint': {'lat': 40.76538, 'lon': -73.81736}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Luke's Roosevelt Hospital Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'BRANY - Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Rex Healthcare', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Research of Winston-Salem, Inc.', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43615', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '76135', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Health First Medical Group', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '78205', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Peripheral Vascular Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53226', 'city': 'Wauwatosa', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The Wisconsin Heart Hospital', 'geoPoint': {'lat': 43.04946, 'lon': -88.00759}}], 'overallOfficials': [{'name': 'Rui Avelar, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Angiotech Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Angiotech Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}