An interventional study of HELIOS biodegradable polymer sirolimus-eluting stents in Coronary Artery Disease, sponsored by Xijing Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
HELIOS biodegradable polymer sirolimus-eluting stents
Device: HELIOS biodegradable polymer sirolimus-eluting stents
HELIOS biodegradable polymer sirolimus-eluting stents
target lesion failure (TLF)
a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization
Time frame: 12 months
Patient oriented composite endpoint
a composite endpoint of all cause death, all myocardial infarction and all revascularization
Time frame: 1、6、12、36、60 months
all cause death
including cardiac and non-cardiac death
Time frame: 1、6、12、36、60 months
cardiac death
death from cardiac cause
Time frame: 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.
Time frame: 1、6、12、36、60 months
Stent thrombosis
Stent thrombosis (ST) was defined according to Academic Research Consortium criteria
Time frame: 1、6、12、36、60 months
target lesion revascularization
TLR was defined as any repeat revascularization by PCI or CABG
Time frame: 1、6、12、36、60 months
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