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

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: Nano

Study type: Observational

Funder types: Other

Identifiers

NCT02929030

NANOxijing001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,500 participants in 1 patient group

NANO Plus SES

Description:

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.

Treatment:

Device: Nano