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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2025
  • participants needed
    3000
  • sponsor
    Xijing Hospital
Updated on 3 February 2022
sirolimus
myocardial infarction
infarct
biodegradable polymer
arterial disease
revascularisation

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.

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.

Details
Condition Coronary Artery Disease
Treatment HELIOS biodegradable polymer sirolimus-eluting stents
Clinical Study IdentifierNCT03916432
SponsorXijing Hospital
Last Modified on3 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

-85 years old, male or non-pregnancy female; 2Patients with coronary artery
disease who match the indication of stent implantation; 3Patients 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
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