Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 8:50 AM
Study NCT ID:
NCT04470934
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2020-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1302}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2020-07-10', 'studyFirstSubmitQcDate': '2020-07-10', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure (TLF)', 'timeFrame': 'at 12 months', 'description': 'Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR).'}], 'secondaryOutcomes': [{'measure': 'Target Lesion Failure (TLF)', 'timeFrame': 'at 24 months', 'description': 'Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR).'}, {'measure': 'ischemia driven target lesion revascularization (TLR)', 'timeFrame': 'at 12 months'}, {'measure': 'ischemia driven target lesion revascularization (TLR)', 'timeFrame': 'at 24 months'}, {'measure': 'all-cause death, cardiac death', 'timeFrame': 'at 12 months'}, {'measure': 'all-cause death, cardiac death', 'timeFrame': 'at 24 months'}, {'measure': 'all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)', 'timeFrame': 'at 12 months'}, {'measure': 'all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)', 'timeFrame': 'at 24 months'}, {'measure': 'major adverse coronary event (MACE)', 'timeFrame': 'at 12 months', 'description': 'major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization'}, {'measure': 'major adverse coronary event (MACE)', 'timeFrame': 'at 24 months', 'description': 'major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization'}, {'measure': 'Dual Antiplatelet Therapy (DAPT) compliance', 'timeFrame': 'at 4 weeks'}, {'measure': 'Dual Antiplatelet Therapy (DAPT) compliance', 'timeFrame': 'at 3 months'}, {'measure': 'Probable or definite stent-thrombosis of In-stent treated lesions', 'timeFrame': 'accumulated at 12 months'}, {'measure': 'Probable or definite stent-thrombosis of In-stent treated lesions', 'timeFrame': 'accumulated at 24 months'}, {'measure': 'Procedural success', 'timeFrame': 'immediately after procedure', 'description': 'final diameter stenosis \\< 30 % without flow-limiting dissections'}, {'measure': 'Bleeding complications according to the Bleeding Academic Research Consortium (BARC)', 'timeFrame': 'accumulated at 3 months'}, {'measure': 'Bleeding complications according to the Bleeding Academic Research Consortium (BARC)', 'timeFrame': 'accumulated at 12 months'}, {'measure': 'Bleeding complications according to the Bleeding Academic Research Consortium (BARC)', 'timeFrame': 'accumulated at 24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Myocardial Ischemia', 'drug-coated balloon catheter'], 'conditions': ['Coronary Artery Disease', 'Myocardial Ischaemia']}, 'referencesModule': {'references': [{'pmid': '37003986', 'type': 'DERIVED', 'citation': 'Otto S, Diaz VAJ, Weilenmann D, Cuculi F, Nuruddin AA, Leibundgut G, Alfonso F, Wan Ahmad WA, Pyxaras S, Rittger H, Steen P, Gaede L, Schulze C, Wohrle J, Rosenberg M, Waliszewski MW. Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial. BMC Cardiovasc Disord. 2023 Mar 31;23(1):176. doi: 10.1186/s12872-023-03187-x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The product under investigation will be used in routine clinical practice according to the latest European Society of Cardiology (ESC) guidelines and according to the Instructions for Use (IFU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).', 'detailedDescription': 'The objective of the study is to assess the continued safety and efficacy of SeQuent® SCB for the treatment of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts. Study goals are based on non-inferiority for Drug-Coated Balloon (DCB) compared to Paclitaxel-Coated Balloon (PCB) and Dru-eluting Stents (DES) (historical data) with 80% power. Primary and secondary outcome variables are international accepted parameters in stent-trials, which sufficiently describe the efficacy and safety of the investigated device and allow clinical conclusions. Additional attention will be paid to those patients who received, by observation, a shortened dual antiplatelet therapy (DAPT).\n\nThe aim of the study is to assess the safety and efficacy of the SeQuent® SCB in the treatment of coronary artery disease with reference vessel diameters between ≥ 2 mm and ≤ 4 mm with suitable lesion lengths. There is no limitation of lesion lengths. In case the lesion is longer than 34 mm, more than one stent needs to be used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a single-armed, prospective, international, multi-center, post-market study in patients with coronary artery disease and indication for PCI either due to anginal symptoms and a relevant stenotic coronary lesion during angiography or due to documented ischemia by non-invasive or invasive functional testing.\n\nAll patients who undergo a target intervention with the SCB will be followed for 12 and 24 months after initial PCI.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All common significant coronary lesions\n* Target lesion length \\>34mm need to be covered with at least 2 devices\n* Patients eligible for this study must be at least 18 years of age\n* The patient must fulfil the standard recommendations for percutaneous coronary intervention (PCI), based on the last ESC recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment\n\nExclusion Criteria:\n\n* Intolerance to sirolimus\n* Allergy to components of the coating\n* Pregnancy and lactation\n* Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized\n* Cardiogenic shock\n* Risk of an intraluminal thrombus\n* Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy\n* Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior\n* Severe allergy to contrast media\n* Lesions which are untreatable with PCI or other interventional techniques\n* Patients with an ejection fraction of \\< 30 %\n* Vascular reference diameter \\< 2.00 mm\n* Treatment of the left stem (first section of the left coronary artery)\n* Indication for a bypass surgery\n* Contraindication for whichever accompanying medication is necessary"}, 'identificationModule': {'nctId': 'NCT04470934', 'acronym': 'SCORE', 'briefTitle': 'SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Melsungen AG'}, 'officialTitle': 'PMCF - Study on the Performance/Safety of SeQuent® Sirolimus-Coated Balloon (SCB, Investigational Device) in Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'AAG-O-H-1913'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SeQuent® SCB drug-coated balloon catheter', 'type': 'DEVICE', 'description': 'treatment of coronary artery disease with SeQuent® SCB of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07747', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Sylvia Otto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Jena - Klinik für Innere Medizin I'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Melsungen AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}