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

Sponsor

Xijing Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00552656

Collaborator

Air Force Military Medical University, China (Other), core laboratory of Cardiovascular Institute & Fuwai Hospital (Other), Shanghai MicroPort Medical (Group) Co., Ltd. (Industry), CCheart Consulting Co., Ltd. (Industry)

1,000

Enrollment

Location

Duration (Months)

23.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease	Device: Firebird(TM) Sirolimus-Eluting Stent

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective, Multicenter Study of Firebird Sirolimus-Eluting Stent for Treatment of Complex Coronary Lesions. Clinical and Angiographic Outcomes of FIREMAN Study

Study Start Date :

Jan 1, 2007

Anticipated Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
1 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.	Device: Firebird(TM) Sirolimus-Eluting Stent balloon expandable stent that made of stainless steel.The length is from 13mm-33mm,and the diameter from 2.5mm-4.0mm Other Names: sirolimus-eluting stent made in China

Arm

Intervention/Treatment

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.

Device: Firebird(TM) Sirolimus-Eluting Stent

balloon expandable stent that made of stainless steel.The length is from 13mm-33mm,and the diameter from 2.5mm-4.0mm

Other Names:

sirolimus-eluting stent made in China

Outcome Measures

Primary Outcome Measures

cumulative MACE (including cardiac death, non-fatal myocardial infarction and target lesion revascularization) [3 years]

Secondary Outcome Measures

angiographic binary restenosis [8 months]
late loss [8 months]
cumulative target vessel revascularization [3 years]
cumulative in-stent thrombosis [3 years]
cumulative stroke [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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