NCT02929030

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Nano	The stent system comprises of 2 components: stent steel platform, antiproliferative drug sirolimus, and stent balloon

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-01-01
• Completion: 2022-01-01
• First posted: 2016-10-10
• Last updated: 2016-12-30

Locations

1 site across 1 country: China