Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT03714802
Status:
UNKNOWN
Last Update Posted:
2019-03-05
First Post:
2018-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-02', 'studyFirstSubmitDate': '2018-09-21', 'studyFirstSubmitQcDate': '2018-10-18', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization', 'timeFrame': '1 year after coronary angiography', 'description': 'record in follow-up'}], 'secondaryOutcomes': [{'measure': 'rate of all cause death', 'timeFrame': '30 days and 12 months after primary angiography', 'description': 'Recorded in follow-up'}, {'measure': 'rate of cardiac death rate', 'timeFrame': '30 days and 12 months after primary angiography', 'description': 'Recorded in follow-up'}, {'measure': 'rate of recurrent myocardial infarction rate', 'timeFrame': '30 days and 12 months after primary angiography', 'description': 'Recorded in follow-up'}, {'measure': 'rate of target vessel revascularization rate', 'timeFrame': '30 days and 12 months after primary angiography', 'description': 'Recorded in follow-up'}, {'measure': 'rate of stent thrombosis', 'timeFrame': '30 days and 12 months after primary angiography', 'description': 'Recorded in follow-up'}, {'measure': 'residual stenosis degree', 'timeFrame': 'Immediately after stent implantation and 12 months after primary angiography', 'description': 'Measured through intravenous ultrasound'}, {'measure': 'residual stenosis of side branch', 'timeFrame': 'Immediately after stent implantation and 12 months after primary angiography', 'description': 'Measured through angiography'}, {'measure': 'late lumen loss', 'timeFrame': 'index procedure and 12 months follow up', 'description': 'Measured through intravenous ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bifurcation lesion', 'percutaneous coronary intervention', 'Szabo', 'T-stenting'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The study will compare clinical outcomes of modified T-stenting with Szabo technique with T-stenting for bifurcation lesions in coronary heart diseases.', 'detailedDescription': 'Accurate deployment of stents in ostial lesions is difficult with traditional angiographic guidance. Szabo technique, which used a second angioplasty guide wire to anchor the stent by passing the proximal end of the anchor wire through the last cell of the stent, demonstrated accurate placement of the stents in ostial locations. In bifurcation lesions, 2-stent strategy positioning with Szabo technique was not investigated. Modified T-stenting with Szabo technique may improve prognosis of bifurcation lesions through reducing stents overlap. There is no clinical trial focuses on the effect and outcome of Szabo technique for coronary artery bifurcation lesions in contrast with conventional strategy.\n\nIn this study, the authors choose the closest 2-stent strategy, T-stenting, as control. We hope to determine whether a planned Szabo 2-stent technique is superior to T-stenting for patients with bifurcation lesions.\n\nPatients with bifurcation lesions will be randomly assigned to receive Szabo 2-stent technique or T-stenting strategy. Clinical outcomes and imaging assessment will be used to estimate their effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must be at least ≥18 years of age.\n* Lesions are eligible for percutaneous coronary intervention (PCI).\n* Patient has stable/unstable angina or myocardial infarction (MI).\n* Bifurcation lesions (Medina 1,1,1/0,1,1/1,0,1) without left main ostial lesions.\n* Downstream lesions could be covered by two stents.\n* Diameter of vessel ≥2.25mm\n* Diameter stenosis in main vessel and side branch ≥ 50% by visual estimation.\n\nExclusion Criteria:\n\n* Severe tortuosity or calcification affected procedural success.\n* Patient was allergic to the study stent or protocol-required concomitant medications.\n* Patient is intolerable to dual anti-platelet therapy.\n* Patient has any other serious medical illness that may reduce life expectancy to\\<12 months.\n* Patient is a woman who is pregnant or nursing.\n* Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.\n* Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.\n* Coronary restenosis.'}, 'identificationModule': {'nctId': 'NCT03714802', 'briefTitle': 'Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases: SZABO Trial', 'orgStudyIdInfo': {'id': 'SZABO Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Szabo T-Stenting Technique', 'description': 'Patients received 2-stents implantation guided with Szabo technique in bifurcation lesion.', 'interventionNames': ['Procedure: Szabo T-Stenting Technique', 'Procedure: T-Stenting Technique']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'T-Stenting Technique', 'description': 'Patients received 2-stents implantation guided with T-stenting technique in bifurcation lesion.', 'interventionNames': ['Procedure: Szabo T-Stenting Technique', 'Procedure: T-Stenting Technique']}], 'interventions': [{'name': 'Szabo T-Stenting Technique', 'type': 'PROCEDURE', 'description': '2-stent strategy was performed using modified T-stenting with Szabo technique in bifurcation lesions. First, stent was implanted in the side branch with Szabo technique. Then, stent was implanted in the main branch. Finally, kissing balloon inflation was performed.', 'armGroupLabels': ['Szabo T-Stenting Technique', 'T-Stenting Technique']}, {'name': 'T-Stenting Technique', 'type': 'PROCEDURE', 'description': '2-stent strategy was performed using traditional T-stenting technique in bifurcation lesions. First, stent was implanted in the side branch with angiographic guidance. Then, stent was implanted in the main branch. Finally, kissing balloon inflation was performed.', 'armGroupLabels': ['Szabo T-Stenting Technique', 'T-Stenting Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongbo Yang, M.D.', 'role': 'CONTACT', 'email': 'yang.hongbo@zs-hospital.sh.cn', 'phone': '13585890793'}, {'name': 'Zheyong Huang, M.D.', 'role': 'CONTACT', 'email': 'huang.zheyong@zs-hospital.sh.cn', 'phone': '13512100180'}, {'name': 'Junbo Ge, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zheyong Huang, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hongbo Yang, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jiatian Cao, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yanan Song, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junbo Ge, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hongbo Yang, M.D.', 'role': 'CONTACT', 'email': 'yang.hongbo@zs-hospital.sh.cn', 'phone': '008613585890793', 'phoneExt': '00862164223006'}, {'name': 'Zheyong Huang, M.D.', 'role': 'CONTACT', 'email': 'huang.zheyong@zs-hospital.sh.cn', 'phone': '008613512100180'}], 'overallOfficials': [{'name': 'Junbo Ge, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Zhongshan Hospital Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Ge', 'investigatorFullName': 'Junbo Ge', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}