Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT00694005
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2008-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C489443', 'term': 'zotarolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 504}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2008-06-05', 'studyFirstSubmitQcDate': '2008-06-06', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diameter stenosis at 8-month follow-up between the kissing balloon inflation and leave alone strategy', 'timeFrame': '8 months', 'description': '8 month after PCI'}], 'secondaryOutcomes': [{'measure': 'Incidence of side branch jail after main vessel stenting according to the stent type used', 'timeFrame': 'Day 1', 'description': 'Day 1 (24 hours after the index procedure)'}, {'measure': 'Angiographic reocclusion rate of side branch', 'timeFrame': '8 months', 'description': '8month after PCI'}, {'measure': 'Angiographic restenosis rate of side branch and the main vessel', 'timeFrame': '8 months', 'description': '8month after PCI'}, {'measure': 'Late loss of side branch and the main vessel between angiography- and FFR-guided side branch procedure', 'timeFrame': '8 months', 'description': '8month after PCI'}, {'measure': 'Angiographic reocclusion, restenosis rate and late loss of the side branch according to the DES type', 'timeFrame': '8 months', 'description': '8month after PCI'}, {'measure': 'Angiographic reocclusion, restenosis rate and late loss of the side branch according to bifurcation angle and bifurcation type', 'timeFrame': '8 months', 'description': '8month after PCI'}, {'measure': 'Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and target vessel revascularization', 'timeFrame': '2 years'}, {'measure': 'FFR of the side branch at post-procedure and at follow-up', 'timeFrame': 'Day 1, 8 months', 'description': 'Day 1 (immediately after the index procedure)and 8month after PCI'}, {'measure': 'Incidence of peri-procedural cardiac enzyme elevation', 'timeFrame': 'Day 1', 'description': 'Day 1 (24 hours after the index procedure)'}, {'measure': 'Fluoroscopic time', 'timeFrame': 'Day 1', 'description': 'Day 1 (immediately after the index procedure)'}, {'measure': 'Procedure time', 'timeFrame': 'Day 1', 'description': 'Day 1 (immediately after the index procedure)'}, {'measure': 'Amount of contrast agent', 'timeFrame': 'Day 1', 'description': 'Day 1 (immediately after the index procedure)'}, {'measure': 'Number of used stents', 'timeFrame': 'Day 1', 'description': 'Day 1 (immediately after the index procedure)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stent', 'bifurcation', 'balloon angioplasty'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Few data are available about the late patency of side branches in association with the currently used stent types and implantation techniques.', 'detailedDescription': 'Among the bifurcation type, bifurcation lesion without significant side branch stenosis (\\<50%) usually did not require side branch stenting, but owing to several putative mechanism including dissection, thrombosis formation, embolization of plaque debris, ostial compromise by displaced stent strut, and snow plow effect, the side branch might be compromised. In this situation, the strategy to achieve optimal results has not been reported. Recently, FFR study showed that most jailed side branch (vessel size \\>2.0 mm. DS\\>50%) after main branch stenting did not have functional significance. We compared strategies with or without routine kissing balloon dilatation for less than 50% stenosis after simple DES crossing for bifurcation lesions (bifurcation type 1.1.0, 1.0.0, and 0.1.0 according to Medina classification) with serial change of FFR measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical\n\n * Patients with angina and documented ischemia or patients with documented silent ischemia\n * Patients who are eligible for intracoronary stenting\n * Age \\>18 years, \\<75 ages\n* Angiographic\n\n * De novo lesion located in a major bifurcation point with the MEDINA classification type 1.1.0, 1.0.0, or 0.1.0\n * Main vessel : \\>= 2.5 mm in vessel size, \\>= 50% in diameter stenosis and =\\< 50 mm in lesion length by visual estimation, in which the lesion is covered with =\\< 2 stents\n * Side branch :\\>= 2.0 mm in vessel size and \\< 50% diameter stenosis by visual estimation\n\nExclusion Criteria:\n\n* History of bleeding diathesis or coagulopathy\n* Pregnant\n* Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus, paclitaxel and zotarolimus\n* Limited life-expectancy (less than 1 year) due to combined serious disease\n* ST-elevation acute myocardial infarction =\\< 2 weeks\n* Characteristics of lesion:\n\n * Left main disease\n * In-stent restenosis\n * Graft vessels\n * TIMI flow =\\< grade 2 in the side branch\n * Chronic total occlusion\n* Renal dysfunction, creatinine \\>= 2.0mg/dL\n* Contraindication to aspirin, clopidogrel or cilostazol'}, 'identificationModule': {'nctId': 'NCT00694005', 'acronym': 'CROSS', 'briefTitle': 'Choice Of Optimal Strategy For Bifurcation Lesions With Normal Side Branch', 'organization': {'class': 'OTHER', 'fullName': 'CardioVascular Research Foundation, Korea'}, 'officialTitle': 'Phase IV Study of the Choice of Optimal Strategy for Bifurcation Lesions With Normal Side Branch', 'orgStudyIdInfo': {'id': '2008-0185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bifurcation stent techniqe', 'description': 'cross over stenting without kissing balloon angioplasty "leave alone"', 'interventionNames': ['Procedure: without kissing balloon angioplasty "leave alone"']}, {'type': 'EXPERIMENTAL', 'label': 'bifurcation stent technique', 'description': 'kissing balloon angioplasty', 'interventionNames': ['Procedure: kissing balloon']}], 'interventions': [{'name': 'kissing balloon', 'type': 'PROCEDURE', 'otherNames': ['Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents'], 'description': 'simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions', 'armGroupLabels': ['bifurcation stent technique']}, {'name': 'without kissing balloon angioplasty "leave alone"', 'type': 'PROCEDURE', 'otherNames': ['sirolimus, zotarolimus, paclitaxel, and everolimus stents'], 'description': 'simultaneous kissing balloon angioplasty during drug-eluting stent implantation for bifurcation coronary lesions', 'armGroupLabels': ['bifurcation stent techniqe']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soonchunhyang University Bucheon Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Busan', 'country': 'South Korea', 'facility': "Busan Saint Mary's Hospital", 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Cheongju-si', 'country': 'South Korea', 'facility': "Cheongju Saint Mary's Hospital", 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Jinju', 'country': 'South Korea', 'facility': 'Kyungsang University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'city': 'Pyeongchon', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.7007, 'lon': 126.932}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Catholic University, Kangnam St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'facility': 'Aju University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Kangwon University Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'overallOfficials': [{'name': 'Seung-Jung Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'CardioVascular Research Foundation, Korea'}}}}