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