Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
Study NCT ID:
NCT03908450
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2019-04-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'angiographies blinded to treatment groups'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-04-07', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'late lumen loss in-segment', 'timeFrame': '6 months', 'description': 'angiographic minimal lumen diameter in-segment at 6 months minus minimal lumen diameter at baseline'}], 'secondaryOutcomes': [{'measure': 'Procedural Success', 'timeFrame': 'in hospital', 'description': '\\< 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE'}, {'measure': 'MACE MACE', 'timeFrame': 'at 6 and at 12 months', 'description': 'cardiac death, target vessel myocardial infarction, and TLR target lesion revascularization in-hospital at 6 and at 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '30898253', 'type': 'BACKGROUND', 'citation': 'Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.'}, {'pmid': '39492703', 'type': 'DERIVED', 'citation': 'Scheller B, Mangner N, Jeger RV, Afan S, Mahfoud F, Woitek FJ, Fahrni G, Schwenke C, Schnorr B, Kleber F. A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions. EuroIntervention. 2024 Nov 4;20(21):e1322-e1329. doi: 10.4244/EIJ-D-23-00868.'}]}, 'descriptionModule': {'briefSummary': 'To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon', 'detailedDescription': 'To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical follow up\n\nKey inclusion criteria: \\> 18 years of age, Clinical evidence of stable or unstable angina or a positive functional study, Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to \\<70% diameter stenosis with positive functional test or symptom of ischemia), Successful lesion preparation (no flow-limiting dissection or a residual stenosis \\> 30%).\n\nKey exclusion criteria: Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI), Intolerance and / or allergy to Sirolimus, Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: iopromide), Patients with an ejection fraction of \\< 30 %, Reference vessel diameter (RVD) \\< 2.5 mm, Contraindication for whichever necessary accompanying medication.\n\nPrimary efficacy endpoint: late lumen loss in-segment at 6 months. Key secondary endpoints: Procedural Success: \\< 30% final diameter stenosis, no flow-limiting dissection (type C or higher), TIMI III flow, and the absence of in-hospital MACE. MACE: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization in-hospital at 6 and at 12 months Individual clinical endpoints at 6 and at 12 months: cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, (stenosis ≥ 50% at follow-up angiography)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical evidence of stable or unstable angina or a positive functional study\n* Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to \\<70% diameter stenosis with positive functional test or symptom of ischemia)\n* Successful lesion preparation (no flow-limiting dissection or a residual stenosis \\> 30%)\n\nExclusion Criteria:\n\n* Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)\n* Intolerance and / or allergy to Sirolimus\n* Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:\n\niopromide)\n\n* Patients with an ejection fraction of \\< 30 %\n* Reference vessel diameter (RVD) \\< 2.5 mm\n* Contraindication for whichever necessary accompanying medication'}, 'identificationModule': {'nctId': 'NCT03908450', 'acronym': 'SCBDENOVO', 'briefTitle': 'Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'InnoRa GmbH'}, 'officialTitle': 'Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter', 'orgStudyIdInfo': {'id': 'SI-DN-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control intervention', 'description': 'Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²)', 'interventionNames': ['Device: PTCA of coronary de novo lesion PCB']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental intervention', 'description': 'Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²)', 'interventionNames': ['Device: PTCA of coronary de novo lesion SCB']}], 'interventions': [{'name': 'PTCA of coronary de novo lesion PCB', 'type': 'DEVICE', 'description': 'PTCA of coronary de novo lesion with drug coated balloon', 'armGroupLabels': ['Control intervention']}, {'name': 'PTCA of coronary de novo lesion SCB', 'type': 'DEVICE', 'description': 'PTCA of coronary de novo lesion with drug coated balloon', 'armGroupLabels': ['Experimental intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg/Saar', 'state': 'Saarland', 'country': 'Germany', 'facility': 'Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes'}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '06886', 'city': 'Wittenberg', 'country': 'Germany', 'facility': 'Klinik für Innere Medizin III - Kardiologie Paul Gerhardt Stift', 'geoPoint': {'lat': 51.8661, 'lon': 12.64973}}, {'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Bruno Scheller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical and Experimental Interventional Cardiology, University of Saarland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InnoRa GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}