NCT01373632

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

Multicenter, Randomized, Non-inferiority Study of Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 570 (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 Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several 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) with durable polymer, comparing with Excel SES.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Firebird 2 sirolimus-eluting stent	the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform
DEVICE	Excel sirolimus-eluting stent	the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-06-01
• Completion: 2013-09-01
• First posted: 2011-06-15
• Last updated: 2011-06-15

Locations

1 site across 1 country: China