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

NCT ID: NCT03916432

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional group

HELIOS biodegradable polymer sirolimus-eluting stents

Group Type EXPERIMENTAL

HELIOS biodegradable polymer sirolimus-eluting stents

Intervention Type DEVICE

HELIOS biodegradable polymer sirolimus-eluting stents

Interventions

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HELIOS biodegradable polymer sirolimus-eluting stents

HELIOS biodegradable polymer sirolimus-eluting stents

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Luhe Hospital

OTHER

Sponsor Role collaborator

Cangzhou People's Hospital

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Shantou University Medical College

OTHER

Sponsor Role collaborator

Western Central Hospital of Hainan Province

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital of Hainan Medical College

UNKNOWN

Sponsor Role collaborator

Huizhou Municipal Central Hospital

OTHER

Sponsor Role collaborator

First People's Hospital of Yulin

OTHER

Sponsor Role collaborator

Shaanxi Armed Police Corps Hospital

UNKNOWN

Sponsor Role collaborator

Xi'an No.3 Hospital

OTHER_GOV

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role collaborator

Ankang Central Hospital

OTHER

Sponsor Role collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role collaborator

Cardiovascular Hospital of Ningxia Medical University

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Kaifeng Central Hospital

OTHER

Sponsor Role collaborator

Xinyang Central Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Zhoupu Hospital, Pudong New Area, Shanghai

UNKNOWN

Sponsor Role collaborator

Shanghai Longhua Hospital

UNKNOWN

Sponsor Role collaborator

Huangshan Shoukang Hospital

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Southern Anhui Medical College

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Harbin Medical University

OTHER

Sponsor Role collaborator

Third Affiliated Hospital of Qiqihar

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Jiamusi

UNKNOWN

Sponsor Role collaborator

Harbin First Hospital

UNKNOWN

Sponsor Role collaborator

The Second Hospital of Shenyang Medical College

OTHER

Sponsor Role collaborator

Yingkou Central Hospital

UNKNOWN

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ling Tao, MD, PhD

Role: STUDY_DIRECTOR

First Affiliated Hospital,Fourth Military Medical University

Locations

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Ling Tao

Xi’an, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Liu, MD, PhD

Role: CONTACT

18602973275

Ruining Zhang, MS

Role: CONTACT

86-029-84775183

References

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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.

Reference Type RESULT
PMID: 25043067 (View on PubMed)

Zheng B, Liu Y, Zhang R, Yang W, Su F, Wang R, Chen D, Shen G, Qiu Y, Wang L, Chen C, Wu Z, Li F, Li J, Li C, Gao C, Tao L; HELIOS Investigators. A novel biodegradable polymer-coated sirolimus-eluting stent: 1-year results of the HELIOS registry. Chin Med J (Engl). 2023 Aug 5;136(15):1848-1854. doi: 10.1097/CM9.0000000000002324.

Reference Type DERIVED
PMID: 37306407 (View on PubMed)

Other Identifiers

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ky20182050-1

Identifier Type: -

Identifier Source: org_study_id

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