Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-17 @ 7:09 PM
Study NCT ID:
NCT02284750
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2014-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two-stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions
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': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 660}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Acute gain', 'timeFrame': 'Intraoperative', 'description': 'The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD)'}, {'measure': 'In-stent restenosis', 'timeFrame': '13 months', 'description': 'In-stent restenosis was defined as ≥50% diameter stenosis at the follow-up angiogram.'}, {'measure': 'Late lumen loss', 'timeFrame': '13 months', 'description': 'The late lumen loss was defined as the difference between post- and follow-up minimal lumen diameter (MLD)'}], 'primaryOutcomes': [{'measure': 'Target lesion failure', 'timeFrame': '12 months', 'description': 'Combined end point of: cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization (TLR).'}], 'secondaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': '12 months'}, {'measure': 'Target-vessel myocardial infarction', 'timeFrame': '12 months'}, {'measure': 'Target lesion revascularisation', 'timeFrame': '12 months'}, {'measure': 'Target vessel revascularisation', 'timeFrame': '12 months'}, {'measure': 'Stent thrombosis', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bifurcation lesion', 'Percutaneous coronary intervention'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '35798473', 'type': 'DERIVED', 'citation': 'Kan J, Zhang JJ, Sheiban I, Santoso T, Munawar M, Tresukosol D, Xu K, Stone GW, Chen SL; DEFINITION II Investigators. 3-Year Outcomes After 2-Stent With Provisional Stenting for Complex Bifurcation Lesions Defined by DEFINITION Criteria. JACC Cardiovasc Interv. 2022 Jul 11;15(13):1310-1320. doi: 10.1016/j.jcin.2022.05.026.'}, {'pmid': '32588060', 'type': 'DERIVED', 'citation': 'Zhang JJ, Ye F, Xu K, Kan J, Tao L, Santoso T, Munawar M, Tresukosol D, Li L, Sheiban I, Li F, Tian NL, Rodriguez AE, Paiboon C, Lavarra F, Lu S, Vichairuangthum K, Zeng H, Chen L, Zhang R, Ding S, Gao F, Jin Z, Hong L, Ma L, Wen S, Wu X, Yang S, Yin WH, Zhang J, Wang Y, Zheng Y, Zhou L, Zhou L, Zhu Y, Xu T, Wang X, Qu H, Tian Y, Lin S, Liu L, Lu Q, Li Q, Li B, Jiang Q, Han L, Gan G, Yu M, Pan D, Shang Z, Zhao Y, Liu Z, Yuan Y, Chen C, Stone GW, Han Y, Chen SL. Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial. Eur Heart J. 2020 Jul 14;41(27):2523-2536. doi: 10.1093/eurheartj/ehaa543.'}, {'pmid': '29511018', 'type': 'DERIVED', 'citation': 'Zhang JJ, Gao XF, Han YL, Kan J, Tao L, Ge Z, Tresukosol D, Lu S, Ma LK, Li F, Yang S, Zhang J, Munawar M, Li L, Zhang RY, Zeng HS, Santoso T, Xie P, Jin ZN, Han L, Yin WH, Qian XS, Li QH, Hong L, Paiboon C, Wang Y, Liu LJ, Zhou L, Wu XM, Wen SY, Lu QH, Yuan JQ, Chen LL, Lavarra F, Rodriguez AE, Zhou LM, Ding SQ, Vichairuangthum K, Zhu YS, Yu MY, Chen C, Sheiban I, Xia Y, Tian YL, Shang ZL, Jiang Q, Zhen YH, Wang X, Ye F, Tian NL, Lin S, Liu ZZ, Chen SL. Treatment effects of systematic two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: rationale and design of a prospective, randomised and multicentre DEFINITION II trial. BMJ Open. 2018 Mar 6;8(3):e020019. doi: 10.1136/bmjopen-2017-020019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the optimal strategy for stenting in coronary bifurcation lesion.', 'detailedDescription': 'The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of two-stenting and simple stenting techniques in patients with complex bifurcation lesions. Based on the previous studies, the rate of 1-year target lesion failure events was around 14% after PCI with provisional stenting. And our previous data showed that this event at 12-month after two-stenting procedure was 7%. Considering the lost to follow-up, it is anticipated that up to 660 patients will be enrolled in the trial. All patients will have repeat angiography at 13 months, with clinical follow-up to 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures;\n* Men and women 18 years and older;.\n* Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology;\n* Native coronary lesion suitable for drug-eluting stent placement;\n* True bifurcation lesions (Medina 0,1,1/1,1,1);\n* Reference vessel diameter in side branch ≥2.5mm by visual estimation;\n* Complex bifurcation lesions based on DEFINITION study.\n\nExclusion Criteria:\n\n* Pregnancy and breast feeding mother;\n* Co-morbidity with an estimated life expectancy of \\< 50 % at 12 months;\n* Scheduled major surgery in the next 12 months;\n* Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;\n* Unable to provide written informed consent, or fail to follow the protocol;\n* Previous enrolment in coronary intervention device investigation during the study period;\n* Patient with STEMI within 24-hour from the onset of chest pain to admission;\n* Restenosis bifurcation lesions.'}, 'identificationModule': {'nctId': 'NCT02284750', 'acronym': 'DEFINITION-II', 'briefTitle': 'Two-stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'A Prospective, Multi-center, Randomized Trial Comparing Two-stent With Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions', 'orgStudyIdInfo': {'id': 'NFH20141029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Two-stenting technique', 'description': 'Percutaneous coronary intervention with DK crush, or culotte technique', 'interventionNames': ['Procedure: Percutaneous coronary intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Provisional stenting technique', 'description': 'Percutaneous coronary intervention with Provisional stenting technique. Stenting of the side branch was required if TIMI flow was \\<3, or ≥ type B dissection after kissing balloon inflation.', 'interventionNames': ['Procedure: Percutaneous coronary intervention']}], 'interventions': [{'name': 'Percutaneous coronary intervention', 'type': 'PROCEDURE', 'otherNames': ['PCI'], 'armGroupLabels': ['Provisional stenting technique', 'Two-stenting technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Shao-Liang Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing First Hospital, Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President', 'investigatorFullName': 'Shaoliang Chen', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}