Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT03916432
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2019-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HELIOS China Registry: Evaluation of the HELIOS Stent in a 'Real-World' Patient Population
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': 3000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'target lesion failure (TLF)', 'timeFrame': '12 months', 'description': 'a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'Patient oriented composite endpoint', 'timeFrame': '1、6、12、36、60 months', 'description': 'a composite endpoint of all cause death, all myocardial infarction and all revascularization'}, {'measure': 'all cause death', 'timeFrame': '1、6、12、36、60 months', 'description': 'including cardiac and non-cardiac death'}, {'measure': 'cardiac death', 'timeFrame': '1、6、12、36、60 months', 'description': 'death from cardiac cause'}, {'measure': 'Myocardial infarction', 'timeFrame': '1、6、12、36、60 months', 'description': 'All myocardial infarction (MI) data were reported based on extended historical definitions.MI was always considered a target vessel, unless there was documented proof that the infarction arose from the nontreated coronary artery.'}, {'measure': 'Stent thrombosis', 'timeFrame': '1、6、12、36、60 months', 'description': 'Stent thrombosis (ST) was defined according to Academic Research Consortium criteria'}, {'measure': 'target lesion revascularization', 'timeFrame': '1、6、12、36、60 months', 'description': 'TLR was defined as any repeat revascularization by PCI or CABG'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '25043067', 'type': 'RESULT', 'citation': 'Yuan F, Chen X, Song X, Wang D, Zhang Z, Li W, Li Z, Li H, Chen X, Huo Y, Wang L, Lu C, Lu Q, Xu B, Li W, Lyu S; HOPE Investigator. Novel completed biodegradable polymer sirolimus-eluting stent versus durable polymer sirolimus-eluting stent in de novo lesions: nine-month angiographic and three-year clinical outcomes of HOPE trial. Chin Med J (Engl). 2014;127(14):2561-6.'}, {'pmid': '41174582', 'type': 'DERIVED', 'citation': 'He X, Liu Y, Yin Z, Li F, van Geuns RJ, Garg S, Onuma Y, Serruys PW, Gao C, Tao L. Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis. BMC Med. 2025 Oct 31;23(1):598. doi: 10.1186/s12916-025-04429-9.'}, {'pmid': '37306407', 'type': 'DERIVED', 'citation': 'Zheng B, Liu Y, Zhang R, Yang W, Su F, Wang R, Chen D, Shen G, Qiu Y, Wang L, Chen C, Wu Z, Li F, Li J, Li C, Gao C, Tao L; HELIOS Investigators. A novel biodegradable polymer-coated sirolimus-eluting stent: 1-year results of the HELIOS registry. Chin Med J (Engl). 2023 Aug 5;136(15):1848-1854. doi: 10.1097/CM9.0000000000002324.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the safety and efficacy of biodegradable polymer sirolimus-eluting coronary stent system (HELIOS) in patients with coronary artery disease . The primary endpoint is target lesion failure, a composite endpoint of cardiac death, target vessel related myocardial infarction and clinically-driven target lesion revascularization at 1 year follow-up.', 'detailedDescription': 'This is a prospective, multicenter, single arm clinical registry investigating the safety and efficacy of biodegradable polymer sirolimus-eluting coronary stent system(HELIOS) in patients with coronary artery disease . The HELIOS (Kimley Medical, Shenzhen, China) completed biodegradable polymer sirolimus-eluting stent (SES) is a novel polylactic-co-glycolic acid (PLGA),polymer cobalt-chromium DES with titanium oxides (TiO) film as the tie-layer.In total, we plan to recruit 3000 patients (HELIOS)in real world setting. The patients will be followed clinically at 1-, 6- month and 1-, 3-, 5-year. All clinical data will be collected and managed by statistical center, clinical endpoint adjudication committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1）18-85 years old, male or non-pregnancy female; 2）Patients with coronary artery disease who match the indication of stent implantation; 3）Patients who can understand the nature of the study, agree to participate and accept clinical follow-up\n\nExclusion Criteria:\n\n1. Patients who can not tolerate the material or medication in this study; Pregnancy or lactation women\n2. Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;\n3. Patients are, in the opinion of the investigator, unable to comply with the requirements of the study protocol'}, 'identificationModule': {'nctId': 'NCT03916432', 'briefTitle': "HELIOS China Registry: Evaluation of the HELIOS Stent in a 'Real-World' Patient Population", 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': "HELIOS China Registry: A Prospective, Single-arm, Multicenter Study to Evaluate the HELIOS Biodegradable Polymer Sirolimus-eluting Stent in a 'Real-World' Patient Population", 'orgStudyIdInfo': {'id': 'ky20182050-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': 'HELIOS biodegradable polymer sirolimus-eluting stents', 'interventionNames': ['Device: HELIOS biodegradable polymer sirolimus-eluting stents']}], 'interventions': [{'name': 'HELIOS biodegradable polymer sirolimus-eluting stents', 'type': 'DEVICE', 'description': 'HELIOS biodegradable polymer sirolimus-eluting stents', 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710054', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Ling Tao', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}], 'centralContacts': [{'name': 'Yi Liu, MD, PhD', 'role': 'CONTACT', 'email': '1391643423@qq.com', 'phone': '18602973275'}, {'name': 'Ruining Zhang, MS', 'role': 'CONTACT', 'email': 'liuyimeishan@hotmail.com', 'phone': '86-029-84775183'}], 'overallOfficials': [{'name': 'Ling Tao, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital，Fourth Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Luhe Hospital', 'class': 'OTHER'}, {'name': "Cangzhou People's Hospital", 'class': 'OTHER'}, {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Shantou University Medical College', 'class': 'OTHER'}, {'name': 'Western Central Hospital of Hainan Province', 'class': 'UNKNOWN'}, {'name': 'Second Affiliated Hospital of Hainan Medical College', 'class': 'UNKNOWN'}, {'name': 'Huizhou Municipal Central Hospital', 'class': 'OTHER'}, {'name': "First People's Hospital of Yulin", 'class': 'OTHER'}, {'name': 'Shaanxi Armed Police Corps Hospital', 'class': 'UNKNOWN'}, {'name': "Xi'an No.3 Hospital", 'class': 'OTHER_GOV'}, {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, {'name': 'Ankang Central Hospital', 'class': 'OTHER'}, {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, {'name': 'Cardiovascular Hospital of Ningxia Medical University', 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}, {'name': 'Kaifeng Central Hospital', 'class': 'OTHER'}, {'name': 'Xinyang Central Hospital', 'class': 'OTHER'}, {'name': "People's Hospital of Zhengzhou University", 'class': 'OTHER'}, {'name': 'Zhoupu Hospital, Pudong New Area, Shanghai', 'class': 'UNKNOWN'}, {'name': 'Shanghai Longhua Hospital', 'class': 'UNKNOWN'}, {'name': 'Huangshan Shoukang Hospital', 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Southern Anhui Medical College', 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'Harbin Medical University', 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital of Qiqihar', 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Jiamusi University', 'class': 'UNKNOWN'}, {'name': 'Harbin First Hospital', 'class': 'UNKNOWN'}, {'name': 'The Second Hospital of Shenyang Medical College', 'class': 'OTHER'}, {'name': 'Yingkou Central Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}