Long Term Efficacy and Safety of Firebird Sirolimus-Eluting Stent In Complex Coronary Lesions

• Conditions: Coronary Disease
• Interventions: Device: Firebird(TM) Sirolimus-Eluting Stent

• Registration Number: NCT00552656
• Lead Sponsor: Xijing Hospital

Brief Summary

The purpose of this study is to investigate the long term efficacy and safety of firebird sirolimus-eluting stent for treatment of complex coronary Lesions.

Detailed Description

Randomized clinical trials and large-scale registry studies have shown that sirolimus-eluting stents (SESs) decrease major adverse cardiovascular event(MACE)and restenosis rates compared with bare metal stents (BMSs), but relatively small proportion of patients of complex lesions were enrolled in these studies. Moreover,with the increase in complexity of lesions, different DES shows different effects. The long term effects of DES for treatment of complex coronary lesions remains to be established. This study aims to investigate the long term efficacy and safety of Firebird sirolimus-eluting stent implantation in a high-risk population, that is, the patients who had complex coronary lesions, including multivessel diseases,diffuse long lesions, left main lesions, chronic total occlusion, bifurcation lesions, small vessel diseases,severe calcification or angulation lesions, ostial lesions, restenotic lesions after bare metel stent implantation .

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-10-31
• Study First Submitted QC: 2007-10-31
• Study First Posted: 2007-11-02
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-11
• Last Update Posted: 2008-08-12
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• the patients who have the indication for coronary interventional therapy
• stable angina pectoris (CCS class I II III IV)or unstable angina pectoris (Braunwald class B＆C，I-II) or documented asymptomatic myocardial ischemia
• reference vessel diameter is of 2.5mm to 4.0mm (estimated by investigator)
• significant(>70%) stenosis of target lesion (estimated by investigator)
• angiographic criteria is complex coronary lesions which includes the followings: multivessel lesions(>or=two vessels), diffuse long lesions with length>or=30mm or need two stents overlapped, small vessel lesions(reference vessel diameter<or=2.5mm estimated by investigator), bifurcation lesions need one or two stents and side branch diameter>2.0mm, chronic total occlusion lesions(>3 months), ostial target lesions(including ostial of right coronary artery,left anterior descending artery and left circumflex artery), severe calcification or angulation(location of target lesion at a >45°bend), protected and unprotected left main lesions, restenosis after bare metal stent implantation(core laboratory decision )
• the patients would like to accept the follow-up and sign the informed consent

Exclusion Criteria

• pregnant or nursing women
• acute myocardial infarction within the preceding one month
• graft lesions after CABG
• implanted other drug-eluting stents at the same time except the designated one
• left ventricle dysfunction with ejection fraction<30%(evaluated by echocardiogram with Simpson's double-chamber method)
• renal dysfunction with serum creatinine level>or=2mg/dl(177umol/L)
• pre-intervention with intravascular brachytherapy or other non-PTCA techniques
• contradictions or allergy to aspirin, heparin, clopidogrel,stainless steel and hypersensitive to contrast media
• anticipated life span < 12 months
• enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Firebird(TM) Sirolimus-Eluting Stent	the group of patients with angiographic results of complex coronary lesions(refer to the definition of protocol)are enrolled and given a clinical follow up and angiographic follow up during the following one year.

Primary Outcome Measures

Name	Time	Method
cumulative MACE (including cardiac death, non-fatal myocardial infarction and target lesion revascularization)	3 years

Secondary Outcome Measures

Name	Time	Method
cumulative target vessel revascularization	3 years
cumulative in-stent thrombosis	3 years
angiographic binary restenosis	8 months
cumulative stroke	3 years
late loss	8 months

Trial Locations

Locations (1)

Department of Cardiology of Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shannxi, China