Long Term Efficacy and Safety of Firebird Sirolimus-Eluting Stent In Complex Coronary Lesions (FIREMAN)
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.
|Study Design:||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|
- cumulative MACE (including cardiac death, non-fatal myocardial infarction and target lesion revascularization) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- angiographic binary restenosis [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- late loss [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- cumulative target vessel revascularization [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- cumulative in-stent thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- cumulative stroke [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||August 2010|
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 Name: sirolimus-eluting stent made in China
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 .
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552656
|Department of Cardiology of Xijing Hospital, Fourth Military Medical University|
|Xi'an, Shannxi, China, 710032|
|Principal Investigator:||Haichang Wang, MD,PhD||Director of Department of Cardiology of Xijing Hospital, Fourth Military Medical University|