Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT01495533
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2011-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2011-12-13', 'studyFirstSubmitQcDate': '2011-12-15', 'lastUpdatePostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'late lumen loss in-segment', 'timeFrame': '6 months', 'description': 'angiographic late lumen loss in-segment assessed by quantitative coronary angiography'}], 'secondaryOutcomes': [{'measure': 'Procedural Success', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 days', 'description': '\\<50% final DS and the absence of in-hospital MACE'}, {'measure': 'Major adverse cardiovascular events', 'timeFrame': '6 months', 'description': 'the occurence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months (before planned control angiography)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['In-stent Arterial Restenosis']}, 'referencesModule': {'references': [{'pmid': '26331782', 'type': 'DERIVED', 'citation': 'Scheller B, Fontaine T, Mangner N, Hoffmann S, Bonaventura K, Clever YP, Chamie D, Costa R, Gershony G, Kelsch B, Kutschera M, Genereux P, Cremers B, Bohm M, Speck U, Abizaid A. A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial. Catheter Cardiovasc Interv. 2016 Jul;88(1):51-9. doi: 10.1002/ccd.26216. Epub 2015 Sep 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon.', 'detailedDescription': 'Prospective, controlled, multicenter, randomized, single-blind trial. The aim is to examine the treatment of coronary Bare Metal Stent restenosis with a drug coated AngioSculpt scoring balloon. Patients are randomized to treatment by an AngioSculpt scoring balloon (no drug coating)or a drug coated AngioSculpt scoring balloon (paclitaxel 3.0 µg/mm²). Primary efficacy endpoint is late lumen loss in-segment at 6 months. Key secondary endpoints include procedural Success, MACE (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 6 months). Individual clinical endpoints include stent thrombosis (ARC), cardiac death, any death, target vessel myocardial infarction, any infarction, clinically driven target lesion revascularization, clinically driven target vessel revascularization, any revascularization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years of age\n* clinical evidence of stable or unstable angina or a positive functional study\n* patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis) within previously placed bare metal stents (BMS)\n\nExclusion Criteria:\n\n* acute myocardial infarction within the past 72 hours\n* chronic renal insufficiency with serum creatinine levels \\>2.0 mg per deciliter%\n* known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or paclitaxel, and sensitivity to contrast media not amenable to premedication\n* concomitant medical illness associated with a life-expectancy of less than two years\n* stented segment length ≥30 mm, vessel diameter \\<2.5 mm, diameter stenosis \\<70%'}, 'identificationModule': {'nctId': 'NCT01495533', 'briefTitle': 'Paclitaxel-coated or Uncoated AngioSculpt Scoring Balloon Catheter', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Treatment of Coronary In-stent Restenosis by a Paclitaxel Coated AngioSculpt Scoring Balloon - a First-in-man Pilot Study', 'orgStudyIdInfo': {'id': 'FIM-DCA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'uncoated AngioSculpt(R)', 'description': 'Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)', 'interventionNames': ['Device: uncoated AngioSculpt(R)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'drug coated AngioSculpt(R)', 'description': 'Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)', 'interventionNames': ['Combination Product: Drug coated AngioSculpt(R)']}], 'interventions': [{'name': 'uncoated AngioSculpt(R)', 'type': 'DEVICE', 'description': 'Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)', 'armGroupLabels': ['uncoated AngioSculpt(R)']}, {'name': 'Drug coated AngioSculpt(R)', 'type': 'COMBINATION_PRODUCT', 'description': 'Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)', 'armGroupLabels': ['drug coated AngioSculpt(R)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Danta Pazzanese Heart Institute', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '66421', 'city': 'Homburg Saar', 'country': 'Germany', 'facility': 'Internal Medicine III, UKS'}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Saarland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}