Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT02198105
Status:
UNKNOWN
Last Update Posted:
2016-07-22
First Post:
2014-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D001733', 'term': 'Bites and Stings'}], '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'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-21', 'studyFirstSubmitDate': '2014-07-18', 'studyFirstSubmitQcDate': '2014-07-21', 'lastUpdatePostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically driven target lesion revascularization (TLR)', 'timeFrame': '6 months', 'description': 'clinically driven target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'clinically driven target vessel revascularization (TVR)', 'timeFrame': '6 months', 'description': 'TVR'}, {'measure': 'Binary restenosis', 'timeFrame': '6 months', 'description': 'Peak Systolic velocity (PSV) \\>2.4'}, {'measure': 'Change in Ankle Brachial Index (ABI)', 'timeFrame': '6 months', 'description': 'Change in ankle brachial index from baseline.'}, {'measure': 'Change in Rutherford-classification', 'timeFrame': '6 months', 'description': 'Change in Rutherford-Classification from Baseline (I-VI)'}, {'measure': 'major cardiac adverse events', 'timeFrame': '6 months', 'description': 'myocardial infarction, stroke, death, cardiovascular death'}, {'measure': 'Amputation', 'timeFrame': '6 months'}, {'measure': 'clinically driven target vessel revascularization (TVR)', 'timeFrame': '12 months'}, {'measure': 'Clinically driven target lesion revascularization (TLR)', 'timeFrame': '12 months'}, {'measure': 'Binary restenosis', 'timeFrame': '12 months'}, {'measure': 'Change in Ankle Brachial Index (ABI)', 'timeFrame': '12 months'}, {'measure': 'Change in Rutherford-classification', 'timeFrame': '12 months'}, {'measure': 'major cardiac adverse events', 'timeFrame': '12 months', 'description': 'myocardial infarction, stroke, death, cardiovascular death'}, {'measure': 'Amputation', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PAD', 'femoropoliteal stenosis/occlusion', 'cutting-balloon', 'drug-coated-balloon'], 'conditions': ['Peripheral Artery Disease', 'Femoropoliteal Stenosis/Occlusion', 'Cutting-balloon', 'Drug-coated-balloon']}, 'descriptionModule': {'briefSummary': 'Observational registry including patients with peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).', 'detailedDescription': 'The registry includes consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).\n\nInterventional procedure:\n\n1. PTA with Cutting-Balloon (60-120 seconds).\n2. PTA with Drug-Coated-Balloon (60 seconds).\n\nTechnical success is defined as\n\n1. no recoil \\>30%\n2. no dissection \\>Type B\n3. no stenting \\>30% of lesion length.\n\nFollow-up of patients after 6 months and 12 months (ABI, Rutherford-classification, MACE, TLR, TVR, Binary Restenosis).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* peripheral artery disease (PAD) with femoro-popliteal stenosis \\>70% or occlusion (vessel diameter 4-6mm)\n* age 18-99\n* informed consent\n\nExclusion Criteria:\n\n* proximal / iliacal stenosis\n* stenosis/occlusion of all arteries below the knee'}, 'identificationModule': {'nctId': 'NCT02198105', 'acronym': 'DEBTRAK', 'briefTitle': 'Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.', 'organization': {'class': 'OTHER', 'fullName': 'Caritasklinik St. Theresia'}, 'officialTitle': 'Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.', 'orgStudyIdInfo': {'id': 'DEBTRAK-Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Femoropopliteal stenosis', 'description': 'Consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis/occlusion.\n\nIntervention with Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon-PTA.', 'interventionNames': ['Device: Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA']}], 'interventions': [{'name': 'Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA', 'type': 'DEVICE', 'description': 'Interventional procedure:\n\n1. PTA with Cutting-Balloon (60-120 seconds).\n2. PTA with DC-Balloon (60 seconds).\n\nTechnical success is defined as\n\n1. no recoil \\>30%\n2. no dissection \\>Type B\n3. no stenting \\>30% of lesion length.', 'armGroupLabels': ['Femoropopliteal stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66113', 'city': 'Saarbrücken', 'state': 'Saarland', 'country': 'Germany', 'facility': 'CaritasKlinikum, St. Theresia', 'geoPoint': {'lat': 49.23262, 'lon': 7.00982}}], 'overallOfficials': [{'name': 'Magnus Baumhäkel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CaritasKlinikum, St. Theresia Saarbrücken, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caritasklinik St. Theresia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Magnus Baumhäkel', 'investigatorFullName': 'Magnus Baumhäkel', 'investigatorAffiliation': 'Caritasklinik St. Theresia'}}}}