Clinical trial NCT02929030: Clinical Performance of Nano Plus Sirolimus-Eluting Stents in Patients With Coronary Artery Disease
Official title: Safety and Efficacy of Polymer-free Sirolimus-eluting Coronary Stents in Patients With Coronary Artery Disease.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Nanjing First Hospital, Nanjing Medical University
First posted: 2016-10-10
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease

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.

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

Primary outcomes:
measure: target lesion failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Target lesion failure
timeFrame: 1、6、12、24、36、48、60 months
measure: Patient oriented composite endpoint
timeFrame: 1、6、12、24、36、48、60 months
measure: all cause death
timeFrame: 1、6、12、24、36、48、60 months
measure: cardiac death
timeFrame: 1、6、12、24、36、48、60 months
measure: Myocardial infarction
timeFrame: 1、6、12、24、36、48、60 months
measure: Stent thrombosis
timeFrame: 1、6、12、24、36、48、60 months
measure: Target lesion revascularization
timeFrame: 1、6、12、24、36、48、60 months
measure: Target vessel revascularization
timeFrame: 1、6、12、24、36、48、60 months
measure: target lesion failure
timeFrame: 1、6、24、36、48、60 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
Study officials:
affiliation: Xijing Hospital
name: Lin Tao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Yao-Jun Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Clinical Hospital affiliated to Harbin Medical University
name: Yue Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daqing oilfield central hospital
name: Zhiqi Sun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.