Back to resultsHELIOS China Registry: Evaluation of the HELIOS Stent in a 'Real-World' Patient Population
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HELIOS biodegradable polymer sirolimus-eluting stents
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
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:
- Patients who can not tolerate the material or medication in this study; Pregnancy or lactation women
- Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
- Patients are, in the opinion of the investigator, unable to comply with the requirements of the study protocol
Sites / Locations
- Ling TaoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional group
Arm Description
HELIOS biodegradable polymer sirolimus-eluting stents
Outcomes
Primary Outcome Measures
target lesion failure (TLF)
a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization
Secondary Outcome Measures
Patient oriented composite endpoint
a composite endpoint of all cause death, all myocardial infarction and all revascularization
all cause death
including cardiac and non-cardiac death
cardiac death
death from cardiac cause
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.
Stent thrombosis
Stent thrombosis (ST) was defined according to Academic Research Consortium criteria
target lesion revascularization
TLR was defined as any repeat revascularization by PCI or CABG
Full Information
NCT ID
NCT03916432
First Posted
April 12, 2019
Last Updated
April 12, 2019
Sponsor
Xijing Hospital
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 Municipal 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
1. Study Identification
Unique Protocol Identification Number
NCT03916432
Brief Title
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
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
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 Municipal 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
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
HELIOS biodegradable polymer sirolimus-eluting stents
Intervention Type
Device
Intervention Name(s)
HELIOS biodegradable polymer sirolimus-eluting stents
Intervention Description
HELIOS biodegradable polymer sirolimus-eluting stents
Primary Outcome Measure Information:
Title
target lesion failure (TLF)
Description
a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patient oriented composite endpoint
Description
a composite endpoint of all cause death, all myocardial infarction and all revascularization
Time Frame
1、6、12、36、60 months
Title
all cause death
Description
including cardiac and non-cardiac death
Time Frame
1、6、12、36、60 months
Title
cardiac death
Description
death from cardiac cause
Time Frame
1、6、12、36、60 months
Title
Myocardial infarction
Description
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.
Time Frame
1、6、12、36、60 months
Title
Stent thrombosis
Description
Stent thrombosis (ST) was defined according to Academic Research Consortium criteria
Time Frame
1、6、12、36、60 months
Title
target lesion revascularization
Description
TLR was defined as any repeat revascularization by PCI or CABG
Time Frame
1、6、12、36、60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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:
Patients who can not tolerate the material or medication in this study; Pregnancy or lactation women
Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
Patients are, in the opinion of the investigator, unable to comply with the requirements of the study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Liu, MD, PhD
Phone
18602973275
Email
1391643423@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruining Zhang, MS
Phone
86-029-84775183
Email
liuyimeishan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling Tao, MD, PhD
Organizational Affiliation
First Affiliated Hospital，Fourth Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Ling Tao
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710054
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
25043067
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.
Results Reference
result
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HELIOS China Registry: Evaluation of the HELIOS Stent in a 'Real-World' Patient Population
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