NCT01257373

Efficacy and Safety of Firebird 2 Stent in Treatment of Complex Coronary Lesions in Diabetes

Efficacy and Safety of Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent in Treatment of Complex Coronary Lesions in Diabetes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,300 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to assess the long-term efficacy and safety of Firebird2 Cobalt-Chromium（CoCr）-alloyed sirolimus-eluting stent in treatment of complex lesions in diabetes.

Detailed description

This clinical trial is an international multi-center prospective clinical registry research, for evaluating the efficacy and safety of Firebird 2 cobalt-chromium alloyed sirolimus-eluting stent in treatment of complex coronary lesions in diabetes. As planned, about 57 research centers all over China, Latin America and Asia-Pacific areas will be involved and, 1300 patients will be enrolled into this research. The implanted stents must all be Firebird2 cobalt-chromium alloyed sirolimus-eluting stent. The patient enrollment will last for 12 months. Clinical follow-up will be done respectively for 30 days, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months. All quitted patients during the study will not be replaced with any substitutes, but categorized in the enrollment failure column. The researcher must state clear the reason of nonenrollment.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent	Firebird2 CoCr-alloyed sirolimus-eluting stent system is the 2nd generation of drug-eluting stent(DES). It was registered successfully on Jan. 16, 2009 in China. This stent is based with a CoCr alloyed metal platform. The length is from 13-33mm, the diameter is from 2.5mm-4.0mm.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-04-01
• Completion: 2013-04-01
• First posted: 2010-12-09
• Last updated: 2010-12-30

Locations

1 site across 1 country: China