Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-06 @ 6:01 PM
Study NCT ID:
NCT02563535
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2015-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-17', 'studyFirstSubmitDate': '2015-09-27', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late Lumen Loss (LLL) in the target lesion documented by angiography', 'timeFrame': '6 months', 'description': 'Late Lumen Loss (LLL) in the target lesion documented by angiography'}], 'secondaryOutcomes': [{'measure': 'Number of events of angiographic occlusive restenosis', 'timeFrame': '6 months', 'description': 'number of events of angiographic occlusive restenosis'}, {'measure': 'Number of events of target lesion revascularization (TLR)', 'timeFrame': '12 months', 'description': 'number of events of target lesion revascularization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\>18 years\n* critical limb ischemia (Rutherford class 4-6)\n* angiographic stenosis\\>50% or occlusion of at least one tibial vessel of at least 40mm for which an interventional treatment is scheduled\n\nExclusion Criteria:\n\n* need for major amputation known before intervention\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'}, 'identificationModule': {'nctId': 'NCT02563535', 'acronym': 'ACOART-BTK', 'briefTitle': 'Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Donato'}, 'orgStudyIdInfo': {'id': 'Arezzo015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug-eluting balloon', 'description': 'angioplasty with Litos drug-eluting balloon', 'interventionNames': ['Device: DEB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional PTA', 'description': 'angioplasty with conventional balloon', 'interventionNames': ['Device: PTA']}], 'interventions': [{'name': 'DEB', 'type': 'DEVICE', 'description': 'angioplasty with Litos drug eluting balloon', 'armGroupLabels': ['Drug-eluting balloon']}, {'name': 'PTA', 'type': 'DEVICE', 'description': 'angioplasty with conventional balloon', 'armGroupLabels': ['conventional 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': 'Ospedale San Donato', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Leonardo Bolognese, MD', 'investigatorAffiliation': 'Ospedale San Donato'}}}}