Clinical Performance of Nano Plus Sirolimus-Eluting Stents in Patients With Coronary Artery Disease

Safety and Efficacy of Polymer-free Sirolimus-eluting Coronary Stents in Patients With Coronary Artery Disease.

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.

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.

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