Clinical trial NCT00552656: Long Term Efficacy and Safety of Firebird Sirolimus-Eluting Stent In Complex Coronary Lesions
Official title: Prospective, Multicenter Study of Firebird Sirolimus-Eluting Stent for Treatment of Complex Coronary Lesions. Clinical and Angiographic Outcomes of FIREMAN Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Disease
Keywords: Angioplasty, Transluminal, Percutaneous Coronary
Drug-eluting stents
Treatment Outcome
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shanghai MicroPort Medical (Group) Co., Ltd.
name: CCheart Consulting Co., Ltd.
First posted: 2007-11-02
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study enrolls a group of high risk population who have angiographic results of complex coronary lesions.

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 .

Eligibility criteria: 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

Primary outcomes:
measure: cumulative MACE (including cardiac death, non-fatal myocardial infarction and target lesion revascularization)
timeFrame: 3 years
Secondary outcomes:
measure: angiographic binary restenosis
timeFrame: 8 months
measure: late loss
timeFrame: 8 months
measure: cumulative target vessel revascularization
timeFrame: 3 years
measure: cumulative in-stent thrombosis
timeFrame: 3 years
measure: cumulative stroke
timeFrame: 3 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Cardiology of Xijing Hospital, Fourth Military Medical University
state: Shannxi
Study officials:
affiliation: Director of Department of Cardiology of Xijing Hospital, Fourth Military Medical University
name: Haichang Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemos PA, Hoye A, Goedhart D, Arampatzis CA, Saia F, van der Giessen WJ, McFadden E, Sianos G, Smits PC, Hofma SH, de Feyter PJ, van Domburg RT, Serruys PW. Clinical, angiographic, and procedural predictors of angiographic restenosis after sirolimus-eluting stent implantation in complex patients: an evaluation from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) study. Circulation. 2004 Mar 23;109(11):1366-70. doi: 10.1161/01.CIR.0000121358.26097.06. Epub 2004 Mar 1.
citation: Li Y, Li CX, Wang HC, Xu B, Fang WY, Ge JB, Wang WM, Qiao SB, Chen JP, Shen WK, Jiang H, Cong HL, Pu XQ, Qin YW, Jin HG, Cao Y, Huang H. Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients: one-year clinical and eight-month angiographic outcomes from the FIREMAN registry. Chin Med J (Engl). 2011 Mar;124(6):817-24.