NCT01375296

China Made Sirolimus Eluting Stent for Intermediate Lesion

China Made Sirolimus Eluting Stent for Treatment of Coronary Intermediate Lesion

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Sirolimus-eluting stent (SES) has been proven to improve outcomes in patients with significant coronary artery diseae(\> 70% lumen diameter narrowing). But, acute coronary syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and the effect of SES in these patients remains unclear. Here the investigators hypothesize that application of China-made SES may improve the clinical outcomes in these setting.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	China-made SES (Firebird 2 and Excel)	patients with coronary 50-70% narrowing treated with China-made SES stent,i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent).
OTHER	routine medicine	patients with coronary 50-70% narrowing treated with routine medicine

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-10-01
• Completion: 2011-11-01
• First posted: 2011-06-17
• Last updated: 2011-06-17

Locations

1 site across 1 country: China