Clinical trial NCT03916432: HELIOS China Registry: Evaluation of the HELIOS Stent in a 'Real-World' Patient Population
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Luhe Hospital
name: Cangzhou People's Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: First Affiliated Hospital of Shantou University Medical College
name: Western Central Hospital of Hainan Province
name: Second Affiliated Hospital of Hainan Medical College
name: Huizhou Municipal Central Hospital
name: First People's Hospital of Yulin
name: Shaanxi Armed Police Corps Hospital
name: Xi'an No.3 Hospital
name: Tang-Du Hospital
name: Ankang Central Hospital
name: General Hospital of Ningxia Medical University
name: Cardiovascular Hospital of Ningxia Medical University
name: First Affiliated Hospital of Xinjiang Medical University
name: Kaifeng Central Hospital
name: Xinyang Central Hospital
name: People's Hospital of Zhengzhou University
name: Zhoupu Hospital, Pudong New Area, Shanghai
name: Shanghai Longhua Hospital
name: Huangshan Shoukang Hospital
name: First Affiliated Hospital of Southern Anhui Medical College
name: First Affiliated Hospital of Harbin Medical University
name: Harbin Medical University
name: Third Affiliated Hospital of Qiqihar
name: First Affiliated Hospital of Jiamusi
name: Harbin First Hospital
name: Second Affiliated Hospital of Shenyang Medical College
name: Yingkou Central Hospital
First posted: 2019-04-16
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: target lesion failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Patient oriented composite endpoint
timeFrame: 1、6、12、36、60 months
measure: all cause death
timeFrame: 1、6、12、36、60 months
measure: cardiac death
timeFrame: 1、6、12、36、60 months
measure: Myocardial infarction
timeFrame: 1、6、12、36、60 months
measure: Stent thrombosis
timeFrame: 1、6、12、36、60 months
measure: target lesion revascularization
timeFrame: 1、6、12、36、60 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Ling Tao
state: Shanxi
Study officials:
affiliation: First Affiliated Hospital，Fourth Military Medical University
name: Ling Tao, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.