HELIOS China Registry: A Prospective, Single-arm, Multicenter Study to Evaluate the HELIOS Biodegradable Polymer Sirolimus-eluting Stent in a 'Real-World' Patient Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- target lesion failure (TLF)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Interventional group
HELIOS biodegradable polymer sirolimus-eluting stents
Intervention: HELIOS biodegradable polymer sirolimus-eluting stents (Device)
Outcomes
Primary Outcomes
target lesion failure (TLF)
Time Frame: 12 months
a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization
Secondary Outcomes
- cardiac death(1、6、12、36、60 months)
- target lesion revascularization(1、6、12、36、60 months)
- all cause death(1、6、12、36、60 months)
- Patient oriented composite endpoint(1、6、12、36、60 months)
- Myocardial infarction(1、6、12、36、60 months)
- Stent thrombosis(1、6、12、36、60 months)