Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT00776906
Status:
COMPLETED
Last Update Posted:
2015-01-21
First Post:
2008-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advance® 18PTX® Balloon Catheter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-19', 'studyFirstSubmitDate': '2008-10-20', 'studyFirstSubmitQcDate': '2008-10-21', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Late Lumen Loss', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'The Advance® 18 PTX® Balloon Catheter study is a clinical trial to study the safety and effectiveness of the Advance 18® PTX® Balloon Catheter in the treatment of lesions in the superficial femoral artery and popliteal artery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age \\>18 years.\n* Able to provide informed consent.\n* Has at least one de novo or restenotic lesion(s) with \\> 70% stenosis documented angiographically of the SFA or popliteal artery. If more than one lesion requires intervention, only one should be treated as a study lesion.\n\nKey Exclusion Criteria:\n\n* Has significant stenosis (\\> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure.\n* Lack of at least one patent runoff vessel with \\< 50% stenosis throughout its course.\n* Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery.'}, 'identificationModule': {'nctId': 'NCT00776906', 'briefTitle': 'Advance® 18PTX® Balloon Catheter Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Advance® 18PTX® Balloon Catheter Study: Treatment of Lesions in Superficial Femoral Artery/Popliteal Artery With a Paclitaxel-coated Balloon', 'orgStudyIdInfo': {'id': '08-008'}, 'secondaryIdInfos': [{'id': '190007, PCBS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'PTX-coated balloon', 'interventionNames': ['Device: Advance® 18PTX® Balloon Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Bare balloon', 'interventionNames': ['Device: Advance® 18LP Balloon Catheter']}], 'interventions': [{'name': 'Advance® 18PTX® Balloon Catheter', 'type': 'DEVICE', 'armGroupLabels': ['1']}, {'name': 'Advance® 18LP Balloon Catheter', 'type': 'DEVICE', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Heart Center Leipzig/Park Hospital', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '83022', 'city': 'Rosenheim', 'country': 'Germany', 'facility': 'Klinikum Rosenheim', 'geoPoint': {'lat': 47.85637, 'lon': 12.12247}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitat Klinik Tubingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '111123', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Endosurgery and Lithotripsy Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}