Coronary Artery Disease
Conditions
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.
Interventions
DEVICENano
The stent system comprises of 2 components: stent steel platform, antiproliferative drug sirolimus, and stent balloon
Sponsors
Nanjing First Hospital, Nanjing Medical University
Xijing Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| target lesion failure (TLF) | 12 months | cardiac death, target vessel related myocardial infarction and/or clinically driven target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient oriented composite endpoint | 1、6、12、24、36、48、60 months | a composite endpoint of all cause death, all myocardial infarction and all revascularization |
| 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 | — |
| Target lesion failure | 1、6、12、24、36、48、60 months | a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization |
| 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 | 1、6、24、36、48、60 months | cardiac death, target vessel related myocardial infarction and/or clinically driven target lesion revascularization |
| Stent thrombosis | 1、6、12、24、36、48、60 months | — |
Countries
China
Contacts
Primary ContactChen Wang, PhD
Backup ContactJin-Zan Cai, MSc
Outcome results
None listed