NCT01328730

The Real-world Firebird 2 Versus Cypher Sirolimus-eluting Stent in Treating Patients With Coronary Artery Disease

Post-marketing Study Comparing the Efficacy and Safety of Firebird 2 Versus Cypher Sirolimus-eluting Stents in Treating Patients With Coronary Artery Disease in China

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 430 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Cypher SES (Cordis, MA) has been proved by several randomized clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai), comparing with Cypher SES.

Conditions

• Coronary Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Firebird 2 SES	The FIREBIRD2™ Rapamycin-Eluting CoCr Coronary Stent is the second generation DES of MicroPort, which based on the new cobalt chromium alloy stent platform. It uses polyolefin polymer, which makes the coating property very remarkable.
DEVICE	Cypher SES	The Cypher SES is based on the 316L platform with Controlled-release, nonresorbable, elastomeric polymer coating.

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-03-01
• Completion: 2013-06-01
• First posted: 2011-04-05
• Last updated: 2011-06-14

Locations

1 site across 1 country: China