Safety and Efficacy of Polymer-free Sirolimus-eluting Coronary Stents in Patients With Coronary Artery Disease.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Xijing Hospital
- Enrollment
- 2500
- Locations
- 1
- Primary Endpoint
- target lesion failure (TLF)
- Last Updated
- 9 years ago
Overview
Brief Summary
The study aims to evaluate the safety and efficacy of polymer-free sirolimus-eluting coronary stent system (NANO plus) 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 polymer-free sirolimus-eluting coronary stent system (NANO plus) in patients with coronary artery disease . In total, we plan to recruit 2500 patients in real world setting. The patients will be followed clinically at 1-, 6- month and 1-, 2-, 3-, 4-, 5-year. All clinical data will be collected and managed by statistical center, clinical endpoint adjudication committee.
Investigators
Tao Ling
Professor
Xijing Hospital
Eligibility Criteria
Inclusion Criteria
- •18-85 years old, male or non-pregnancy female;
- •Patients with coronary artery disease who match the indication of stent implantation;
- •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
Outcomes
Primary Outcomes
target lesion failure (TLF)
Time Frame: 12 months
cardiac death, target vessel related myocardial infarction and/or clinically driven target lesion revascularization
Secondary Outcomes
- cardiac death(1、6、12、24、36、48、60 months)
- Patient oriented composite endpoint(1、6、12、24、36、48、60 months)
- Target lesion failure(1、6、12、24、36、48、60 months)
- Target vessel revascularization(1、6、12、24、36、48、60 months)
- target lesion failure(1、6、24、36、48、60 months)
- all cause death(1、6、12、24、36、48、60 months)
- Myocardial infarction(1、6、12、24、36、48、60 months)
- Stent thrombosis(1、6、12、24、36、48、60 months)
- Target lesion revascularization(1、6、12、24、36、48、60 months)