Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-25 @ 7:21 PM
Study NCT ID:
NCT02216058
Status:
UNKNOWN
Last Update Posted:
2014-08-13
First Post:
2014-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of NOYA Sirolimus-Eluting Stent to Treat 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-12', 'studyFirstSubmitDate': '2014-08-11', 'studyFirstSubmitQcDate': '2014-08-12', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TLF(Target Lesion Failure)', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.', 'detailedDescription': 'A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions. Appropriate patients judged by inclusion and exclusion standards will be preformed stent implantation, and after that all patients will be clinically followed up at 30, 180, 365 days,2 years,3 years,4 years and 5 years. Target Lesion Failure (TLF) found in following-up period as key indicators to evaluate the safety of stents. The arrangement, conclusion and statistical analysis of trial data including clinography and angiography will be fulfilled by independent Data Management Center(DMC) and radiography core laboratory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must be ≥18 of age; male or non-pregnant female.\n* Diagnosis of coronary artery disease.\n* At least one target lesion with a diameter stenosis ≥70% (visual estimate)\n* Acceptable candidate for CABG;\n* The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written Notice of Informed Consent, appropriate Ethics Committee(EC); and the patient is willing to comply with specified follow-up evaluations.\n\nExclusion Criteria:\n\n* Patient has congenital heart disease, severe valve dysfunction, bridge vascular disease, severe heart failure (NYHA ≥ Ⅲ level), or left ventricular ejection fraction ≤ 30%.\n* Patient has undergone previous stenting anywhere within the previous 1 year. Patient has a preoperative renal dysfunction: serum creatinine\\> 2.0mg/dl (176.82umol / L).\n* Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year;\n* Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, Prasugrel, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylene-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately premedicated;\n* Patient is allergic to contrast agent Sirolimus.\n* Patient has a limited life expectancy is less than 12 months.\n* Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.\n* Patient has poor compliance with the judgment of the investigator and can not complete the study as required.\n* Patient who had heart transplant.'}, 'identificationModule': {'nctId': 'NCT02216058', 'briefTitle': 'Safety and Efficacy Study of NOYA Sirolimus-Eluting Stent to Treat Coronary Artery Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medfavour (Beijing) Medical Co., Ltd'}, 'officialTitle': 'A Prospective, Multicenter Trial of NOYA Sirolimus-Eluting Stent With Biodegradable Coating in Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'WR-CT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NOYA', 'description': 'NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System', 'interventionNames': ['Device: NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System']}], 'interventions': [{'name': 'NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System', 'type': 'DEVICE', 'armGroupLabels': ['NOYA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yundai Chen, Dr.', 'role': 'CONTACT', 'email': 'cyundai@medmail.com.cn', 'phone': '010-55499209'}, {'name': 'Yundai Chen, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yundai Chen, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chines PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medfavour (Beijing) Medical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}