Evaluation of the HELIOS Stent for coronary artery disease
HELIOS China Registry: A Prospective, Single-arm, Multicenter Study to Evaluate the HELIOS Biodegradable Polymer Sirolimus-eluting Stent in a 'Real-World' Patient Population
This study is testing a new type of heart stent to see if it helps people with coronary artery disease stay healthy and avoid serious heart problems over the next year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shanxi) |
| Trial ID | NCT03916432 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of the HELIOS biodegradable polymer sirolimus-eluting coronary stent system in patients with coronary artery disease. It is a prospective, multicenter, single-arm clinical registry aiming to recruit 3000 patients in a real-world setting. The primary endpoint is target lesion failure, which includes cardiac death, target vessel-related myocardial infarction, and clinically-driven target lesion revascularization at one year follow-up. Patients will be followed up clinically at various intervals including 1, 6 months, and 1, 3, and 5 years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with coronary artery disease who require stent implantation.
Not a fit: Patients who cannot tolerate the materials or medications used in the study or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective stenting option for patients with coronary artery disease.
How similar studies have performed: Other studies have shown success with similar biodegradable stent technologies, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Xi'an, Shanxi
- Ling Tao — Xi'an, Shanxi, China (Recruiting)
Study contacts
- Study coordinator: Yi Liu, MD, PhD
- Email: 1391643423@qq.com
- Phone: 18602973275
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.