Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT01373632
Status:
UNKNOWN
Last Update Posted:
2011-06-15
First Post:
2011-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 570}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-14', 'studyFirstSubmitDate': '2011-06-13', 'studyFirstSubmitQcDate': '2011-06-14', 'lastUpdatePostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "in-stent late lumen loss at 9 months' angiographic follow-up", 'timeFrame': '9 months', 'description': 'patients are planned to receive angiographic follow-up at 9 months after index procedure, and in-stent late lumen loss will be analyzed'}], 'secondaryOutcomes': [{'measure': 'target vessel failure', 'timeFrame': '2 years after index procedure', 'description': 'defined as the occurrence of any of the following within 1 and 2 years after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularizationof the target vessel (emergency or elective coronaryartery bypass grafting \\[CABG\\] or repeated percutaneous transluminal coronary angioplasty \\[PTCA\\]).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['significant stenosis (>70% of lumen stenosis)', 'epicardial coronary arteries', 'clinical ischemic'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '17442198', 'type': 'BACKGROUND', 'citation': 'Zhang Q, Xu B, Yang YJ, Zhang RY, Li JP, Qiao SB, Zhang JS, Hu J, Qin XW, Hong T, Chen JL, Huo Y, Shen WF, Gao RL. Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result. A prospective, historically controlled, multi-center clinical study. Chin Med J (Engl). 2007 Apr 5;120(7):533-8.'}, {'pmid': '18655114', 'type': 'BACKGROUND', 'citation': 'Han Y, Jing Q, Chen X, Wang S, Ma Y, Liu H, Luan B, Wang G, Li Y, Wang Z, Wang D, Xu B, Gao R. Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents. Catheter Cardiovasc Interv. 2008 Aug 1;72(2):177-83. doi: 10.1002/ccd.21600.'}]}, 'descriptionModule': {'briefSummary': 'Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai) with durable polymer, comparing with Excel SES.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* male or un-pregnant female\n* stenosis \\> 70% in one of major the epicardial coronary arteries\n* no contra-indications of stent implantation\n* singed the informed consent\n\nExclusion Criteria:\n\n* acute myocardial infarction within one week\n* have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy\n* no history of stent implantation within last one-year\n* received other brand coronary stent during index procedure\n* with no achievement of informed consent'}, 'identificationModule': {'nctId': 'NCT01373632', 'acronym': 'FESTA', 'briefTitle': 'Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Multicenter, Randomized, Non-inferiority Study of Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': '20110611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Firebird 2 stent group', 'description': 'the patients who receive Firebird 2 stent', 'interventionNames': ['Device: Firebird 2 sirolimus-eluting stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Excel stent group', 'description': 'the patients who receive Excel stent', 'interventionNames': ['Device: Excel sirolimus-eluting stent']}], 'interventions': [{'name': 'Firebird 2 sirolimus-eluting stent', 'type': 'DEVICE', 'description': 'the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform', 'armGroupLabels': ['Firebird 2 stent group']}, {'name': 'Excel sirolimus-eluting stent', 'type': 'DEVICE', 'description': 'the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform', 'armGroupLabels': ['Excel stent group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'WeiFeng Shen, MD, PhD', 'role': 'CONTACT', 'email': 'rjshenweifeng@yahoo.com.cn', 'phone': '86-21-64370045', 'phoneExt': '665215'}, {'name': 'Xian Zhang, MD', 'role': 'CONTACT', 'phone': '86-21-64370045', 'phoneExt': '665215'}, {'name': 'WeiFeng Shen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Qi Zhang, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'oldOrganization': 'Cardiovascular Department'}}}}