Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-06 @ 2:57 AM
Study NCT ID:
NCT01798433
Status:
COMPLETED
Last Update Posted:
2019-01-02
First Post:
2013-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STRATEGY for Left Main Coronary Bifurcation Lesion II
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-29', 'studyFirstSubmitDate': '2013-02-11', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion failure', 'timeFrame': '12-month', 'description': 'defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': '12-month', 'description': 'All deaths were considered cardiac unless a definite non-cardiac cause could be established.'}, {'measure': 'Angiographic in-segment restenosis rate', 'timeFrame': '9 months', 'description': 'as measured by 9-month quantitative coronary analysis'}, {'measure': 'Target vessel revascularization (TVR)', 'timeFrame': '12-month', 'description': 'TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery.'}, {'measure': 'Stent thrombosis', 'timeFrame': '12-month', 'description': 'Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.'}, {'measure': 'Myocardial infarction (MI)', 'timeFrame': '12-month', 'description': 'MI was defined as elevated cardiac enzymes (troponin or MB fraction of creatine kinase, CK-MB) more than the upper limit of the normal value with ischemic symptoms or electrocardiography findings indicative of ischemia that was not related to the index procedure.'}, {'measure': 'Target lesion revascularization (TLR)', 'timeFrame': '12-month', 'description': 'TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.'}, {'measure': 'Periprocedural CK-MB elevation', 'timeFrame': 'the first 48 hours after PCI', 'description': 'Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure.'}, {'measure': 'Procedure success rate', 'timeFrame': 'the first 48 hours after PCI'}, {'measure': 'Procedure time', 'timeFrame': 'immediate after PCI'}, {'measure': 'Amount of contrast dye', 'timeFrame': 'immediate after PCI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Angioplasty', 'Transluminal', 'Percutaneous Coronary'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'In patients with unprotected left main (LM) true bifurcation lesion (cohort A), elective 2-stent strategy is superior to provisional strategy at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.\n\nIn patients with unprotected LM non-true bifurcation lesion (cohort B), 1-stent technique with mandatory final kissing ballooning is superior to 1-stent technique without kissing ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥20 years\n2. Left main bifurcation lesion on coronary angiography\n3. Significant myocardial ischemia Main vessel (left main coronary artery and left anterior descending artery) and/or side branch (left circumflex artery) diameter stenosis \\> 75%, or diameter stenosis 50-75% with angina and/or objective evidence of ischemia in the non-invasive stress test\n4. Significant size of the main branch (left anterior descending artery) and side branch (left cirmflex artery) - The reference diameter of both branches ≥ 2.5 mm by visual estimation\n\nExclusion Criteria:\n\n1. The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus\n2. Patients who have received DES implantation in the target lesion prior to enrollment'}, 'identificationModule': {'nctId': 'NCT01798433', 'acronym': 'STRATEGY-II', 'briefTitle': 'STRATEGY for Left Main Coronary Bifurcation Lesion II', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Prospective, Multi-center, Randomized Study to Evaluate the Optimal Strategy for Side Branch Treatment in Patients With Left Main Coronary Bifurcation Lesion', 'orgStudyIdInfo': {'id': '2012-12-039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One stent technique alone', 'description': 'One stent technique alone for non-true LM bifurcation', 'interventionNames': ['Device: One stent technique alone']}, {'type': 'EXPERIMENTAL', 'label': 'One stent technique + Elective FKB', 'description': 'One stent technique + Elective FKB for non-true LM bifurcation', 'interventionNames': ['Device: One stent technique + Elective FKB']}, {'type': 'EXPERIMENTAL', 'label': 'Provisional approach', 'description': 'Provisional approach for true LM bifurcation', 'interventionNames': ['Procedure: Provisional approach']}, {'type': 'EXPERIMENTAL', 'label': 'Elective 2-stent', 'description': 'Elective 2-stent for true LM bifurcation', 'interventionNames': ['Device: Elective 2-stent']}], 'interventions': [{'name': 'One stent technique alone', 'type': 'DEVICE', 'description': 'One stent technique alone with drug-eluting stent', 'armGroupLabels': ['One stent technique alone']}, {'name': 'One stent technique + Elective FKB', 'type': 'DEVICE', 'description': 'One stent technique + Elective FKB with drug-eluting stents + balloon', 'armGroupLabels': ['One stent technique + Elective FKB']}, {'name': 'Provisional approach', 'type': 'PROCEDURE', 'description': 'Provisional approach with drung-eluting stents', 'armGroupLabels': ['Provisional approach']}, {'name': 'Elective 2-stent', 'type': 'DEVICE', 'description': 'Elective 2-stent with drug-eluting stents', 'armGroupLabels': ['Elective 2-stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyeon-Cheol Gwon, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyeon-Cheol Gwon', 'investigatorAffiliation': 'Samsung Medical Center'}}}}