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| Name | Class |
|---|---|
| Beijing Luhe Hospital | OTHER |
| Cangzhou People's Hospital | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| First Affiliated Hospital of Shantou University Medical College |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental | HELIOS biodegradable polymer sirolimus-eluting stents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HELIOS biodegradable polymer sirolimus-eluting stents | Device | HELIOS biodegradable polymer sirolimus-eluting stents |
|
| Measure | Description | Time Frame |
|---|---|---|
| target lesion failure (TLF) | a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient oriented composite endpoint | a composite endpoint of all cause death, all myocardial infarction and all revascularization | 1、6、12、36、60 months |
| all cause death | including cardiac and non-cardiac death |
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Inclusion Criteria:
1)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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Liu, MD, PhD | Contact | 18602973275 | 1391643423@qq.com | |
| Ruining Zhang, MS | Contact | 86-029-84775183 | liuyimeishan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ling Tao, MD, PhD | First Affiliated Hospital,Fourth Military Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ling Tao | Recruiting | Xi’an | Shanxi | 710054 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25043067 | Result | 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. | |
| 41174582 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Western Central Hospital of Hainan Province | UNKNOWN |
| Second Affiliated Hospital of Hainan Medical College | UNKNOWN |
| Huizhou Municipal Central Hospital | OTHER |
| First People's Hospital of Yulin | OTHER |
| Shaanxi Armed Police Corps Hospital | UNKNOWN |
| Xi'an No.3 Hospital | OTHER_GOV |
| Tang-Du Hospital | OTHER |
| Ankang Central Hospital | OTHER |
| General Hospital of Ningxia Medical University | OTHER |
| Cardiovascular Hospital of Ningxia Medical University | UNKNOWN |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| Kaifeng Central Hospital | OTHER |
| Xinyang Central Hospital | OTHER |
| People's Hospital of Zhengzhou University | OTHER |
| Zhoupu Hospital, Pudong New Area, Shanghai | UNKNOWN |
| Shanghai Longhua Hospital | UNKNOWN |
| Huangshan Shoukang Hospital | UNKNOWN |
| First Affiliated Hospital of Southern Anhui Medical College | UNKNOWN |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| Harbin Medical University | OTHER |
| Third Affiliated Hospital of Qiqihar | UNKNOWN |
| First Affiliated Hospital of Jiamusi University | OTHER |
| Harbin First Hospital | UNKNOWN |
| The Second Hospital of Shenyang Medical College | OTHER |
| Yingkou Central Hospital | UNKNOWN |
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| 1、6、12、36、60 months |
| cardiac death | death from cardiac cause | 1、6、12、36、60 months |
| Myocardial infarction | 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. | 1、6、12、36、60 months |
| Stent thrombosis | Stent thrombosis (ST) was defined according to Academic Research Consortium criteria | 1、6、12、36、60 months |
| target lesion revascularization | TLR was defined as any repeat revascularization by PCI or CABG | 1、6、12、36、60 months |
| 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. |
| 37306407 | Derived | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |