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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Nano


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NANO Plus SES<br>All patients will be treated with NANO plus sirolimus-eluting stent. Patients will be prescribed with clopidogrel and aspirin before the index procedure. The lesions will be predilted if necessary before stent implantation. There are no specific limitations on coronary lesions according the study criteria. | Device: Nano<br>* The stent system comprises of 2 components: stent steel platform, antiproliferative drug sirolimus, and stent balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target lesion failure (TLF) | cardiac death, target vessel related myocardial infarction and/or clinically driven target lesion revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization | 1、6、12、24、36、48、60 months | 
| Patient oriented composite endpoint | a composite endpoint of all cause death, all myocardial infarction and all revascularization | 1、6、12、24、36、48、60 months | 
| all cause death |  | 1、6、12、24、36、48、60 months | 
| cardiac 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 | 
| Target vessel revascularization |  | 1、6、12、24、36、48、60 months | 
| target lesion failure | cardiac death, target vessel related myocardial infarction and/or clinically driven target lesion revascularization | 1、6、24、36、48、60 months |