Coronary Artery DiseaseNCT03916432
HELIOS China Registry: Evaluation of the HELIOS Stent in a 'Real-World' Patient Population
A study testing HELIOS biodegradable polymer sirolimus-eluting stents in people with Coronary Artery Disease, run by Xijing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- HELIOS biodegradable polymer sirolimus-eluting stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- HELIOS biodegradable polymer sirolimus-eluting stents
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HELIOS biodegradable polymer sirolimus-eluting stentsDevice
HELIOS biodegradable polymer sirolimus-eluting stents
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | HELIOS biodegradable polymer sirolimus-eluting stents Receives: Device: HELIOS biodegradable polymer sirolimus-eluting stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
target lesion failure (TLF)
a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization
Measured: 12 months
Secondary outcomes (6)
Patient oriented composite endpoint
a composite endpoint of all cause death, all myocardial infarction and all revascularization
Measured: 1、6、12、36、60 months
all cause death
including cardiac and non-cardiac death
Measured: 1、6、12、36、60 months
cardiac death
death from cardiac cause
Measured: 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.
Measured: 1、6、12、36、60 months
Stent thrombosis
Stent thrombosis (ST) was defined according to Academic Research Consortium criteria
Measured: 1、6、12、36、60 months
target lesion revascularization
TLR was defined as any repeat revascularization by PCI or CABG
Measured: 1、6、12、36、60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Dec 2018
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- 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, The Second Affiliated Hospital of Hainan Medical University, 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, China, 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 University, The Second Hospital of Shenyang Medical College, Yingkou Central Hospital
- Responsible party
- Sponsor
- Investigators
- Ling Tao, MD, PhD, Study director, First Affiliated Hospital，Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916432
- Sponsor's protocol ID
- ky20182050-1
- Status last verified
- Nov 2018
- First submitted
- 12 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25043067He X, Liu Y, Yin Z, Li F, van Geuns RJ, Garg S, Onuma Y, Serruys PW, Gao C, Tao L. Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis. BMC Med. 2025 Oct 31;23(1):598. doi: 10.1186/s12916-025-04429-9.
PubMed 41174582Zheng 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.
PubMed 37306407
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03916432
- Acronym / sponsor ID
- ky20182050-1
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- 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, The Second Affiliated Hospital of Hainan Medical University, 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, China, 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 University, The Second Hospital of Shenyang Medical College, Yingkou Central Hospital
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Device: HELIOS biodegradable polymer sirolimus-eluting stentsHELIOS biodegradable polymer sirolimus-eluting stents |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HELIOS biodegradable polymer sirolimus-eluting stentsHELIOS biodegradable polymer sirolimus-eluting stents | Device | Interventional group |
Primary outcome
target lesion failure (TLF)
Time frame: 12 months
a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization
6 secondary outcomes
Patient oriented composite endpoint
Time frame: 1、6、12、36、60 months
all cause death
Time frame: 1、6、12、36、60 months
cardiac death
Time frame: 1、6、12、36、60 months
Myocardial infarction
Time frame: 1、6、12、36、60 months
Stent thrombosis
Time frame: 1、6、12、36、60 months
target lesion revascularization
Time frame: 1、6、12、36、60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Results publication: PubMed 25043067Yuan 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.
- Derived from this study: PubMed 41174582He X, Liu Y, Yin Z, Li F, van Geuns RJ, Garg S, Onuma Y, Serruys PW, Gao C, Tao L. Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis. BMC Med. 2025 Oct 31;23(1):598. doi: 10.1186/s12916-025-04429-9.
- Derived from this study: PubMed 37306407Zheng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Tao, MD, PhD study director
First Affiliated Hospital，Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HELIOS biodegradable polymer sirolimus-eluting stents in people with Coronary Artery Disease, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Liu, MD, PhD (18602973275, 1391643423@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target lesion failure (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03916432, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.