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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT03916432
• Lead Sponsor: Xijing Hospital

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 Timeline

• Status Verified: 2018-11
• Study Start: 2018-12-01
• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-12
• Last Update Submitted: 2019-04-12
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-16
• Primary Completion: 2021-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
target lesion failure (TLF)	12 months	a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
cardiac death	1、6、12、36、60 months	death from cardiac cause
target lesion revascularization	1、6、12、36、60 months	TLR was defined as any repeat revascularization by PCI or CABG
all cause death	1、6、12、36、60 months	including cardiac and non-cardiac death
Patient oriented composite endpoint	1、6、12、36、60 months	a composite endpoint of all cause death, all myocardial infarction and all revascularization
Stent thrombosis	1、6、12、36、60 months	Stent thrombosis (ST) was defined according to Academic Research Consortium criteria
Myocardial infarction	1、6、12、36、60 months	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.

Trial Locations

Locations (1)

Ling Tao; 🇨🇳 Xi'an, Shanxi, China