Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-04-22 @ 5:12 PM
Study NCT ID:
NCT02750605
Status:
COMPLETED
Last Update Posted:
2022-12-30
First Post:
2016-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-29', 'studyFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2016-04-22', 'lastUpdatePostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary patency of treated crural vessels', 'timeFrame': '12 months', 'description': 'Evaluation with MRA (Magnetic Resonans Angiography) at 12 months, regarding binary restenosis or occlusion in the treated arterial segment. Proportion of treated segments that remains open.'}, {'measure': 'Clinical driven target lesion revascularization (TLR)', 'timeFrame': '12 months', 'description': 'Porportion of patients that needs retreatment in in the monitored arterial segment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peripheral Vascular Diseases']}, 'referencesModule': {'references': [{'pmid': '41263159', 'type': 'DERIVED', 'citation': 'Fransson T, Mohammed Y, Gottsater A, Resch T. Prospective Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus Conventional Balloon Angioplasty in Treating Below the Knee Arterial Lesions in Chronic Limb Threatening Ischemia: The CRURAL DEB Study. J Endovasc Ther. 2025 Nov 20:15266028251388746. doi: 10.1177/15266028251388746. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study\n\nResults will be defined as:\n\nLimb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years.\n\nPrimary endpoints:\n\nPrimary Patency at 12 months, TLR (clinical driven),\n\nSecondary endpoints:\n\nEvent free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critical limb ischemia. Rutherford class 4-6\n* Crural disease, long lesions, more than 2 cm.\n* Life expectancy \\> 1year\n* \\> 18 years\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients disapproval\n* Allergy to drug or contrast'}, 'identificationModule': {'nctId': 'NCT02750605', 'briefTitle': 'DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'Skane University Hospital'}, 'officialTitle': 'Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries', 'orgStudyIdInfo': {'id': 'TF3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug eluting balloon angioplasty', 'description': 'Intervention with DEB angioplasty in long lesions of crural arteries', 'interventionNames': ['Device: DEB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plain old balloon angioplasty', 'description': 'Intervention with plain old balloon angioplasty POBA in long lesions of crural arteries', 'interventionNames': ['Device: POBA']}], 'interventions': [{'name': 'DEB', 'type': 'DEVICE', 'description': 'Intervention with drug eluting balloon.', 'armGroupLabels': ['Drug eluting balloon angioplasty']}, {'name': 'POBA', 'type': 'DEVICE', 'description': 'Intervention with old technology as comparison', 'armGroupLabels': ['Plain old balloon angioplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23594', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Vascular center', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Torbjörn Fransson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SUS, Malmö'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skane University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Vascular Surgery', 'investigatorFullName': 'Torbjorn Fransson', 'investigatorAffiliation': 'Skane University Hospital'}}}}