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| Name | Class |
|---|---|
| Nanjing First Hospital, Nanjing Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NANO Plus SES | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nano | Device | The stent system comprises of 2 components: stent steel platform, antiproliferative drug sirolimus, and stent balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| target lesion failure (TLF) | cardiac death, target vessel related myocardial infarction and/or clinically driven target lesion revascularization | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with coronary artery disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Wang, PhD | Contact | 15802929290 | ||
| Jin-Zan Cai, MSc | Contact | 15720800327 |
| Name | Affiliation | Role |
|---|---|---|
| Lin Tao, PhD | Xijing Hospital | Principal Investigator |
| Yao-Jun Zhang, PhD | Nanjing First Hospital, Nanjing Medical University | Principal Investigator |
| Yue Li, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xi’an | Shanxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27497357 | Background | Suwannasom P, Onuma Y, Benit E, Gach O, von Birgelen C, Hofma SH, Sotomi Y, Bo X, Zhang YJ, Gao R, Garcia-Garcia HM, Wykrzykowska JJ, de Winter RJ, Serruys PW. Evaluation of vascular healing of polymer-free sirolimus-eluting stents in native coronary artery stenosis: a serial follow-up at three and six months with optical coherence tomography imaging. EuroIntervention. 2016 Aug 5;12(5):e574-83. doi: 10.4244/EIJV12I5A97. | |
| 24890170 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| The First Clinical Hospital affiliated to Harbin Medical University |
| Principal Investigator |
| Zhiqi Sun, PhD | Daqing oilfield central hospital | Principal Investigator |
| Background |
| Zhang Y, Chen F, Muramatsu T, Xu B, Li Z, Ge J, He Q, Yang Z, Li S, Wang L, Wang H, He B, Li K, Qi G, Li T, Zeng H, Peng J, Jiang T, Zeng Q, Zhu J, Fu G, Bourantas CV, Serruys PW, Huo Y. Nine-month angiographic and two-year clinical follow-up of polymer-free sirolimus-eluting stent versus durable-polymer sirolimus-eluting stent for coronary artery disease: the Nano randomized trial. Chin Med J (Engl). 2014;127(11):2153-8. |
| 41174582 | Derived | He X, Liu Y, Yin Z, Li F, van Geuns RJ, Garg S, Onuma Y, Serruys PW, Gao C, Tao L. Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis. BMC Med. 2025 Oct 31;23(1):598. doi: 10.1186/s12916-025-04429-9. |
| 34772347 | Derived | Dai Y, Wang R, Chen F, Zhang Y, Liu Y, Huang H, Yang P, Zhang R, Zheng B, Gao C, Chen Y, Tao L. Clinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3 years results from the NANO multicenter Registry. BMC Cardiovasc Disord. 2021 Nov 12;21(1):537. doi: 10.1186/s12872-021-02356-0. |
| 31961057 | Derived | Liu Y, Zhang Y, Li Y, Qi T, Pan D, Wang H, Liu C, Ma D, Fang Z, Zhang R, Mou F, Tao L; NANO All-Comers Registry Investigators. One-year clinical results of the NANO registry: A multicenter, prospective all-comers registry study in patients receiving implantation of a polymer-free sirolimus-eluting stent. Catheter Cardiovasc Interv. 2020 Feb;95 Suppl 1:658-664. doi: 10.1002/ccd.28734. Epub 2020 Jan 21. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |