Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-26 @ 8:38 PM
Study NCT ID:
NCT00693251
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2008-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Stenting Strategy For True Bifurcation Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}], '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': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-16', 'studyFirstSubmitDate': '2008-06-05', 'studyFirstSubmitQcDate': '2008-06-06', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Angiographic binary restenosis rate (diameter stenosis >= 50%) at 8 months in either main or side branch', 'timeFrame': '8 months'}], 'secondaryOutcomes': [{'measure': 'Composite of major cardiac adverse events (MACE) including death, MI, stent thrombosis and ischemia-driven target vessel revascularization', 'timeFrame': '2 years'}, {'measure': 'Reocclusion rate at the side branch at 8 month angiographic follow-up', 'timeFrame': '8 months'}, {'measure': 'Late loss at the main vessel and the side branch', 'timeFrame': '8 months'}, {'measure': 'Restenosis rate at the main vessel and/or side branch', 'timeFrame': '8 months'}, {'measure': 'Influence of bifurcation angle', 'timeFrame': '8 months'}, {'measure': 'Influence of new three segment bifurcation QCA software', 'timeFrame': '8 months'}, {'measure': 'Fluoroscopic time', 'timeFrame': 'baseline'}, {'measure': 'Procedure time', 'timeFrame': 'baseline'}, {'measure': 'Amount of contrast agent', 'timeFrame': 'baseline'}, {'measure': 'Number of used stents', 'timeFrame': 'baseline'}, {'measure': 'FFR assessment in the side branch', 'timeFrame': 'baseline and 8 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stent', 'bifurcation', 'coronary artery stenosis', 'balloon angioplasty'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'It is unclear which stenting strategy will be optimal for true bifurcation coronary lesions.', 'detailedDescription': 'The outcome of percutaneous coronary intervention of bifurcation lesions with bare-metal stents is hindered by increased rates of procedural complications and long-term major adverse cardiac events compared with non-bifurcated lesions.1 Randomized studies have demonstrated that drug-eluting stents reduce restenosis when used in relatively simple lesions; and recent data have demonstrated efficacy of the sirolimus-eluting stent for bifurcation lesions compared with historical data of BMS. In one study of bifurcation lesions, the overall restenosis rate was 23%, with the majority of side branch restenoses occurring at the ostium after use of a T-stenting technique. Indeed, side branch restenosis occurred in 16.7% after T-stenting, compared with 7.1% after other stenting techniques.\n\nThe "crush" technique of bifurcation stenting with DESs was introduced by Colombo et al. in 2003 as a relatively simple technique that ensures complete coverage of the side branch ostium, thereby facilitating drug delivery at this site. Initial data of 20 patients treated with this technique with SES suggest that it is a safe method, with an acceptable rate of procedural complications and no further adverse events up to 30 days follow-up. Recently, angiographic data have shown the importance of simultaneous kissing balloon post-dilation in reducing restenosis and need for target lesion revascularization. They also reported that compared to T-stenting, crushing with final kissing balloon dilatation was associated with lower rate of restenosis and target lesion revascularization. Consequently, the crushing is currently most promising technique in treating bifurcation lesions using two stents. However, despite the advance of bifurcation stenting technique, the superiority of bifurcation stenting with crushing technique over simple stenting in bifurcation lesion has not been demonstrated.\n\nTherefore, we conducted the prospective randomized study comparing crushing technique with final kissing balloon dilatation and a simple technique (main vessel stenting and provisional T-stenting) for treatment of true bifurcation lesions.'}, '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 seems to be covered with =\\< 2 stents\n * Side branch : \\>= 2.0 mm in vessel size, \\>= 50% in diameter stenosis, and \\< 20 mm in lesion length by visual estimation, in which the lesion seems to be covered with single stent\n\nExclusion Criteria:\n\n* History of bleeding diathesis or coagulopathy\n* Pregnant\n* Known hypersensitivity or contra-indication to contrast agent, heparin, sirolimus and paclitaxel\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 * Chronic total occlusion\n * TIMI flow =\\< grade 2 in the side branch\n* Renal dysfunction, creatinine \\>= 2.0mg/dL\n* Contraindication to aspirin, clopidogrel or cilostazol\n* LV ejection fraction =\\< 35%'}, 'identificationModule': {'nctId': 'NCT00693251', 'acronym': 'PERFECT', 'briefTitle': 'Optimal Stenting Strategy For True Bifurcation Lesions', 'organization': {'class': 'OTHER', 'fullName': 'CardioVascular Research Foundation, Korea'}, 'officialTitle': 'Phase IV Study of Optimal Stenting Strategy For True Bifurcation Lesions', 'orgStudyIdInfo': {'id': '2007-0714'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bifurcation stent technique', 'description': 'crush technique', 'interventionNames': ['Procedure: Crush technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bifurcation stent techniqe', 'description': 'provisional T stenting', 'interventionNames': ['Procedure: provisional T stenting']}], 'interventions': [{'name': 'Crush technique', 'type': 'PROCEDURE', 'otherNames': ['Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents'], 'description': 'Crush technique', 'armGroupLabels': ['bifurcation stent technique']}, {'name': 'provisional T stenting', 'type': 'PROCEDURE', 'otherNames': ['Sirolimus, Paclitaxel, Zotarolimus and Everolimus stents'], 'description': 'Provisional T stenting', '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': 'Chuncheon', 'country': 'South Korea', 'facility': 'Kangwon University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'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': 'Seoul', 'country': 'South Korea', 'facility': 'Korea Veterans 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}}], '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'}}}}