HELIOS China Registry: Evaluation of the HELIOS Stent in a 'Real-World' Patient Population

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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HELIOS China Registry: A Prospective, Single-arm, Multicenter Study to Evaluate the HELIOS Biodegradable Polymer Sirolimus-eluting Stent in a 'Real-World' Patient Population

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: HELIOS biodegradable polymer sirolimus-eluting stents


Participation Criteria
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Eligibility Criteria
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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: Patients who can not tolerate the material or medication in this study; Pregnancy or lactation women Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint; Patients are, in the opinion of the investigator, unable to comply with the requirements of the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>HELIOS biodegradable polymer sirolimus-eluting stents | Device: HELIOS biodegradable polymer sirolimus-eluting stents<br>* HELIOS biodegradable polymer sirolimus-eluting stents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |