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

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ClinicalTrials.gov Identifier: NCT03916432
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Beijing Luhe Hospital
Cangzhou People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First Affiliated Hospital of Shantou University Medical College
Western Central Hospital of Hainan Province
Second Affiliated Hospital of Hainan Medical College
Huizhou Central Hospital
First People's Hospital of Yulin
Shaanxi Armed Police Corps Hospital
Xi'an No.3 Hospital
Tang-Du Hospital
Ankang Central Hospital
General Hospital of Ningxia Medical University
Cardiovascular Hospital of Ningxia Medical University
First Affiliated Hospital of Xinjiang Medical University
Kaifeng Central Hospital
Xinyang Central Hospital
People's Hospital of Zhengzhou University
Zhoupu Hospital, Pudong New Area, Shanghai
Shanghai Longhua Hospital
Huangshan Shoukang Hospital
First Affiliated Hospital of Southern Anhui Medical College
First Affiliated Hospital of Harbin Medical University
Harbin Medical University
Third Affiliated Hospital of Qiqihar
First Affiliated Hospital of Jiamusi
Harbin First Hospital
Second Affiliated Hospital of Shenyang Medical College
Yingkou Central Hospital
Information provided by (Responsible Party):
Xijing Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: HELIOS biodegradable polymer sirolimus-eluting stents Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

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




Primary Outcome Measures :
  1. target lesion failure (TLF) [ Time Frame: 12 months ]
    a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization


Secondary Outcome Measures :
  1. Patient oriented composite endpoint [ Time Frame: 1、6、12、36、60 months ]
    a composite endpoint of all cause death, all myocardial infarction and all revascularization

  2. all cause death [ Time Frame: 1、6、12、36、60 months ]
    including cardiac and non-cardiac death

  3. cardiac death [ Time Frame: 1、6、12、36、60 months ]
    death from cardiac cause

  4. Myocardial infarction [ Time Frame: 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.

  5. Stent thrombosis [ Time Frame: 1、6、12、36、60 months ]
    Stent thrombosis (ST) was defined according to Academic Research Consortium criteria

  6. target lesion revascularization [ Time Frame: 1、6、12、36、60 months ]
    TLR was defined as any repeat revascularization by PCI or CABG



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916432


Contacts
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Contact: Yi Liu, MD, PhD 18602973275 1391643423@qq.com
Contact: Ruining Zhang, MS 86-029-84775183 liuyimeishan@hotmail.com

Locations
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China, Shanxi
Ling Tao Recruiting
Xi'an, Shanxi, China, 710054
Sponsors and Collaborators
Xijing Hospital
Beijing Luhe Hospital
Cangzhou People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First Affiliated Hospital of Shantou University Medical College
Western Central Hospital of Hainan Province
Second Affiliated Hospital of Hainan Medical College
Huizhou Central Hospital
First People's Hospital of Yulin
Shaanxi Armed Police Corps Hospital
Xi'an No.3 Hospital
Tang-Du Hospital
Ankang Central Hospital
General Hospital of Ningxia Medical University
Cardiovascular Hospital of Ningxia Medical University
First Affiliated Hospital of Xinjiang Medical University
Kaifeng Central Hospital
Xinyang Central Hospital
People's Hospital of Zhengzhou University
Zhoupu Hospital, Pudong New Area, Shanghai
Shanghai Longhua Hospital
Huangshan Shoukang Hospital
First Affiliated Hospital of Southern Anhui Medical College
First Affiliated Hospital of Harbin Medical University
Harbin Medical University
Third Affiliated Hospital of Qiqihar
First Affiliated Hospital of Jiamusi
Harbin First Hospital
Second Affiliated Hospital of Shenyang Medical College
Yingkou Central Hospital
Investigators
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Study Director: Ling Tao, MD, PhD First Affiliated Hospital,Fourth Military Medical University

Publications of Results:
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03916432     History of Changes
Other Study ID Numbers: ky20182050-1
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: November 2018

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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

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs