Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 10:35 PM
Study NCT ID:
NCT01373658
Status:
UNKNOWN
Last Update Posted:
2011-06-15
First Post:
2011-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Registry of Yinyi Stent (SERY-II)
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-13', 'studyFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2011-06-13', 'lastUpdatePostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'late lumen loss', 'timeFrame': '12 months', 'description': 'Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 12-month angiographic follow-up.'}], 'secondaryOutcomes': [{'measure': 'major adverse cardiac events', 'timeFrame': '12 months', 'description': 'including cardiac death, re-infarction, and target vessel revascularization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may prevent these complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-80 years old\n* both gender\n* native coronary lesion\n* narrowing \\> 70%\n* vessel size 2.5-4.0 in diameter\n\nExclusion Criteria:\n\n* without informed consent,\n* ST elevation myocardial infarction within 7 days,\n* patient with ≤ 70% coronary narrowing at target lesion,\n* left main lesion,\n* multivessel narrowing need more than 3 stent implantations,\n* by-pass graft,\n* abnormal liver function before randomization,\n* active hepatitis or muscular disease,\n* impaired renal function with serum creatinine level \\> 3mg/dl,\n* impaired left ventricular function with LVEF \\< 30%,\n* participate in other studies.'}, 'identificationModule': {'nctId': 'NCT01373658', 'acronym': 'SERY-II', 'briefTitle': 'Safety and Efficacy Registry of Yinyi Stent (SERY-II)', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent', 'orgStudyIdInfo': {'id': 'RJH20100910'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yinyi stent', 'interventionNames': ['Device: Yinyi stent']}], 'interventions': [{'name': 'Yinyi stent', 'type': 'DEVICE', 'description': 'subjects with Yinyi stent implantation', 'armGroupLabels': ['Yinyi stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruiyan Zhang, MD', 'role': 'CONTACT', 'email': 'zhangruiyan@263.net', 'phone': '862164370045', 'phoneExt': '665215'}], 'facility': 'ruijin hospital, Shanghai Jiao Tong University, School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ruiyan Zhang, MD', 'role': 'CONTACT', 'email': 'zhangruiyan@263.net', 'phone': '862164370045', 'phoneExt': '665215'}], 'overallOfficials': [{'name': 'Ruiyan Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Weifeng Shen', 'oldOrganization': 'Ruijin hospital, shanghai jiao tong university school of medicine'}}}}