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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: HELIOS biodegradable polymer sirolimus-eluting stents

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 Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Liu, MD, PhD; Phone Number: 18602973275; Email: 1391643423@qq.com
• Study Contact Backup: Name: Ruining Zhang, MS; Phone Number: 86-029-84775183; Email: liuyimeishan@hotmail.com

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710054
      • Recruiting
      • Ling Tao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; HELIOS biodegradable polymer sirolimus-eluting stents	Device: HELIOS biodegradable polymer sirolimus-eluting stents; HELIOS biodegradable polymer sirolimus-eluting stents

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Tang-Du Hospital; General Hospital of Ningxia Medical University; First Affiliated Hospital of Xinjiang Medical University; Huizhou Municipal Central Hospital; Harbin Medical University; First Affiliated Hospital of Harbin Medical University; First Affiliated Hospital of Shantou University Medical College; Beijing Luhe Hospital; Xinyang Central Hospital; Ankang Central Hospital; First People's Hospital of Yulin; Xi'an No.3 Hospital; Kaifeng Central Hospital; Cangzhou People's Hospital; People's Hospital of Zhengzhou University; Western Central Hospital of Hainan Province; Second Affiliated Hospital of Hainan Medical College; Shaanxi Armed Police Corps Hospital; Cardiovascular Hospital of Ningxia Medical University; Zhoupu Hospital, Pudong New Area, Shanghai; Shanghai Longhua Hospital; Huangshan Shoukang Hospital; First Affiliated Hospital of Southern Anhui Medical College; Third Affiliated Hospital of Qiqihar; First Affiliated Hospital of Jiamusi; Harbin First Hospital; Second Affiliated Hospital of Shenyang Medical College; Yingkou Central Hospital
• Investigators: Study Director: Ling Tao, MD, PhD, First Affiliated Hospital，Fourth Military Medical University

Publications and helpful links

General Publications

• 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 lesions: nine-month angiographic and three-year clinical outcomes of HOPE trial. Chin Med J (Engl). 2014;127(14):2561-6.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: ky20182050-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes