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

Coronary Disease Clinical Trial

— FIREMAN  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00552656
• Other study ID #: XJ-20060914
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 31, 2007
• Last updated: August 11, 2008
• Start date: January 2007
• Est. completion date: August 2010

Study information

• Verified date: August 2008
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

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

Locations

Country	Name	City	State
China	Department of Cardiology of Xijing Hospital, Fourth Military Medical University	Xi'an	Shannxi

Sponsors (5)

Lead Sponsor	Collaborator
Xijing Hospital	CCheart Consulting Co., Ltd., core laboratory of Cardiovascular Institute & Fuwai Hospital, Fourth Military Medical University, Shanghai MicroPort Medical (Group) Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Epub 2004 Mar 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative MACE (including cardiac death, non-fatal myocardial infarction and target lesion revascularization)		3 years	Yes
Secondary	angiographic binary restenosis		8 months	No
Secondary	late loss		8 months	No
Secondary	cumulative target vessel revascularization		3 years	No
Secondary	cumulative in-stent thrombosis		3 years	Yes
Secondary	cumulative stroke		3 years	Yes