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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02929030
• Other study ID #: NANOxijing001
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2016
• Last updated: December 29, 2016
• Start date: August 2016
• Est. completion date: January 2022

Study information

• Verified date: December 2016
• Source: Xijing Hospital
• Contact: Chen Wang, PhD
• Phone: 15802929290
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: January 2022
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Nano
The stent system comprises of 2 components: stent steel platform, antiproliferative drug sirolimus, and stent balloon

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Xijing Hospital	Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Suwannasom P, Onuma Y, Benit E, Gach O, von Birgelen C, Hofma SH, Sotomi Y, Bo X, Zhang YJ, Gao R, García-García 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target lesion failure (TLF)	cardiac death, target vessel related myocardial infarction and/or clinically driven target lesion revascularization	12 months	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	all cause death		1?6?12?24?36?48?60 months	Yes
Secondary	cardiac death		1?6?12?24?36?48?60 months	Yes
Secondary	Myocardial infarction		1?6?12?24?36?48?60 months	Yes
Secondary	Stent thrombosis		1?6?12?24?36?48?60 months	Yes
Secondary	Target lesion revascularization		1?6?12?24?36?48?60 months	No
Secondary	Target vessel revascularization		1?6?12?24?36?48?60 months	No
Secondary	target lesion failure	cardiac death, target vessel related myocardial infarction and/or clinically driven target lesion revascularization	1?6?24?36?48?60 months	Yes