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

• Conditions: Coronary Artery Disease
• Interventions: Device: Nano

• Registration Number: NCT02929030
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-29
• Last Update Posted: 2016-12-30
• Primary Completion: 2018-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NANO Plus SES	Nano	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.

Primary Outcome Measures

Name	Time	Method
target lesion failure (TLF)	12 months	cardiac death, target vessel related myocardial infarction and/or clinically driven target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
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
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
cardiac death	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
all cause 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

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shanxi, China