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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03916432
• Other study ID #: ky20182050-1
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2025

Study information

• Verified date: November 2018
• Source: Xijing Hospital
• Contact: Yi Liu, MD, PhD
• Phone: 18602973275
• Email: 1391643423[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• HELIOS biodegradable polymer sirolimus-eluting stents
HELIOS biodegradable polymer sirolimus-eluting stents

Locations

Country	Name	City	State
China	Ling Tao	Xi'an	Shanxi

Sponsors (30)

Lead Sponsor

Collaborator

Xijing Hospital

Ankang Central Hospital, Beijing Luhe Hospital, Cangzhou People's Hospital, Cardiovascular Hospital of Ningxia Medical University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Jiamusi, First Affiliated Hospital of Shantou University Medical College, First Affiliated Hospital of Southern Anhui Medical College, First Affiliated Hospital of Xinjiang Medical University, First People's Hospital of Yulin, General Hospital of Ningxia Medical University, Harbin First Hospital, Harbin Medical University, Huangshan Shoukang Hospital, Huizhou Central Hospital, Kaifeng Central Hospital, People's Hospital of Zhengzhou University, Second Affiliated Hospital of Hainan Medical College, Second Affiliated Hospital of Shenyang Medical College, Shaanxi Armed Police Corps Hospital, Shanghai Longhua Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Tang-Du Hospital, Third Affiliated Hospital of Qiqihar, Western Central Hospital of Hainan Province, Xi'an No.3 Hospital, Xinyang Central Hospital, Yingkou Central Hospital, Zhoupu Hospital, Pudong New Area, Shanghai

Country where clinical trial is conducted

China, 

References & Publications (1)

Yuan F, Chen X, Song X, Wang D, Zhang Z, Li W, Li Z, Li H, Chen X, Huo Y, Wang L, Lu C, Lu Q, Xu B, Li W, Lyu S; HOPE Investigator. Novel completed biodegradable polymer sirolimus-eluting stent versus durable polymer sirolimus-eluting stent in de novo les — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target lesion failure (TLF)	a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization	12 months
Secondary	Patient oriented composite endpoint	a composite endpoint of all cause death, all myocardial infarction and all revascularization	1?6?12?36?60 months
Secondary	all cause death	including cardiac and non-cardiac death	1?6?12?36?60 months
Secondary	cardiac death	death from cardiac cause	1?6?12?36?60 months
Secondary	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.	1?6?12?36?60 months
Secondary	Stent thrombosis	Stent thrombosis (ST) was defined according to Academic Research Consortium criteria	1?6?12?36?60 months
Secondary	target lesion revascularization	TLR was defined as any repeat revascularization by PCI or CABG	1?6?12?36?60 months