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

HELIOS China Registry: A Prospective, Single-arm, Multicenter Study to Evaluate the HELIOS Biodegradable Polymer Sirolimus-eluting Stent in a 'Real-World' Patient Population

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03916432

Enrollment

3000

Registered

2019-04-16

Start date

2018-12-01

Completion date

2025-12-01

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICEHELIOS biodegradable polymer sirolimus-eluting stents

HELIOS biodegradable polymer sirolimus-eluting stents

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
all cause death	1、6、12、36、60 months	including cardiac and non-cardiac death
cardiac death	1、6、12、36、60 months	death from cardiac cause
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
target lesion revascularization	1、6、12、36、60 months	TLR was defined as any repeat revascularization by PCI or CABG
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.

Countries

China

Contacts

Primary ContactYi Liu, MD, PhD

1391643423@qq.com18602973275

Backup ContactRuining Zhang, MS

liuyimeishan@hotmail.com86-029-84775183

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026