Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-04-14 @ 10:26 AM
Study NCT ID:
NCT01558505
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
2012-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-26', 'studyFirstSubmitDate': '2012-03-17', 'studyFirstSubmitQcDate': '2012-03-19', 'lastUpdatePostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'angiographic binary restenosis', 'timeFrame': '12 months', 'description': 'incidence of binary restenosis'}], 'secondaryOutcomes': [{'measure': 'major amputation', 'timeFrame': '24 motnhs', 'description': 'incidence of major amputation'}, {'measure': 'target lesion revascularization', 'timeFrame': '24 months', 'description': 'incidence of target lesion revascularization'}, {'measure': 'vessel reocclusion', 'timeFrame': '24 months', 'description': 'incidence of vessel reocclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['critical limb ischemia', 'drug-eluting balloon', 'restenosis'], 'conditions': ['Critical Limb Ischemia']}, 'referencesModule': {'references': [{'pmid': '23797811', 'type': 'DERIVED', 'citation': 'Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21. doi: 10.1161/CIRCULATIONAHA.113.001811.'}]}, 'descriptionModule': {'briefSummary': 'Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\>18 years\n* angiographic stenosis\\>50% or occlusion of one below-knee vessel\n\nExclusion Criteria:\n\n* allergy to Paclitaxel\n* contraindication for combined antiplatelet treatment\n* life expectancy \\<1 year\n* hypersensitivity or contraindication to one of the study drugs\n* lack of consent\n* need for amputation'}, 'identificationModule': {'nctId': 'NCT01558505', 'acronym': 'DEBATE-BTK', 'briefTitle': 'Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Donato'}, 'officialTitle': 'Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study', 'orgStudyIdInfo': {'id': 'Arezzo005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard PTA', 'description': 'conventional balloon angioplasty', 'interventionNames': ['Device: POBA']}, {'type': 'EXPERIMENTAL', 'label': 'Drug-eluting balloon angioplasty', 'description': 'paclitaxel-eluting balloon angioplasty', 'interventionNames': ['Device: PEB']}], 'interventions': [{'name': 'PEB', 'type': 'DEVICE', 'description': 'paclitaxel-eluting balloon angioplasty', 'armGroupLabels': ['Drug-eluting balloon angioplasty']}, {'name': 'POBA', 'type': 'DEVICE', 'description': 'conventional balloon angioplasty', 'armGroupLabels': ['standard PTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52100', 'city': 'Arezzo', 'state': 'AR', 'country': 'Italy', 'facility': 'Cardiovascular Department, Ospedale S.Donato', 'geoPoint': {'lat': 43.46276, 'lon': 11.88068}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leonardo Bolognese, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Leonardo Bolognese, MD', 'investigatorAffiliation': 'Ospedale San Donato'}}}}