Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-26 @ 8:11 PM
Study NCT ID:
NCT02648334
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 443}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the event rate of composite event', 'timeFrame': '1 year', 'description': 'all cause death, revascularization due to amputation or clinical evidence'}], 'secondaryOutcomes': [{'measure': 'all cause death', 'timeFrame': '2 years'}, {'measure': 'cardiac death', 'timeFrame': '2 years'}, {'measure': 'myocardial infarction', 'timeFrame': '2 years'}, {'measure': 'stroke', 'timeFrame': '2 years'}, {'measure': 'amputation of target limb', 'timeFrame': '2 years'}, {'measure': 'target lesion revascularization', 'timeFrame': '2 years'}, {'measure': 'The change of Rutherford classification', 'timeFrame': '2 years'}, {'measure': 'The change of ABI(ankle-brachial index) score', 'timeFrame': '2 years'}, {'measure': 'MACE', 'timeFrame': '2 years', 'description': 'major adverse cardiac event(death, myocardial infarction, stroke)'}, {'measure': 'thrombosis', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug-Coated Balloon', 'Superficial Femoral artery', 'popliteal peripheral Artery'], 'conditions': ['Angioplasty, Balloon', 'Catheterization, Peripheral', 'Popliteal Artery', 'Femoral Artery']}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and effectiveness Percutaneous Transluminal Angioplasty(PTA) using Drug-Coated Balloons for the treatment of Superficial Femoral and popliteal peripheral Artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 19 and above\n* Subject with claudication or critical limb ischemia(Rutherford classification level 2\\~5)\n* Subject with total occlusion or stenosis ≥70%(de novo, restenosis)\n* Vessel diameter 4\\~6mm\n* Success to guide wire pass\n* Patients who don't have known hypersensitivity or allergy for dual-platelets\n* Willing and able to provide informed written consent\n\nExclusion Criteria:\n\n* Acute stage\n* Acute thrombosis in target limb or target vessel\n* Failure to guide wire pass\n* Distal outflow\n* Lesion with poor inflow\n* Life expectancy ≤ 2 years\n* Allergic to paclitaxel\n* Pregnant or breast feeding woman or disagree with contraception or having children"}, 'identificationModule': {'nctId': 'NCT02648334', 'acronym': 'DCB-SFA', 'briefTitle': 'Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Randomized Comparison of Drug-Coated Balloons for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease: Prospective, Multicenter, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'AMCCV2015-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IN.PACT drug coated balloon', 'description': 'IN.PACT drug coated balloon', 'interventionNames': ['Device: IN.PACT drug coated balloon']}, {'type': 'EXPERIMENTAL', 'label': 'Lutonix drug coated balloon', 'description': 'Lutonix drug coated balloon', 'interventionNames': ['Device: Lutonix drug coated balloon']}], 'interventions': [{'name': 'IN.PACT drug coated balloon', 'type': 'DEVICE', 'armGroupLabels': ['IN.PACT drug coated balloon']}, {'name': 'Lutonix drug coated balloon', 'type': 'DEVICE', 'armGroupLabels': ['Lutonix drug coated balloon']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Changwon', 'country': 'South Korea', 'facility': 'Gyeongsang National University Changwon Hospital', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Goyang-si', 'country': 'South Korea', 'facility': 'Myongji Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul national university Bundang hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Jesushospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Dong-A Medical Center', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Inje University Pusan Paik Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Veterans Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Sejong', 'country': 'South Korea', 'facility': 'Chungnam National University Sejong Hospital', 'geoPoint': {'lat': 36.59245, 'lon': 127.29223}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Veterans Hospital Service Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is not publicly funded trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Whan Lee, M.D., Ph.D.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Division of Cardiology', 'investigatorFullName': 'Seung-Whan Lee, M.D., Ph.D.', 'investigatorAffiliation': 'Asan Medical Center'}}}}