An observational study in Coronary Disease, sponsored by Xijing Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2008-08-12.
Sponsored by Xijing Hospital · Observational
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.
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 .
2,867 studies on the registry are indexed under Coronary Disease; 309 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 465 across 958 observational studies indexed under Coronary Disease.
Browse Coronary Disease studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
Counted across the registry records on this site, refreshed daily.
the study enrolls a group of high risk population who have angiographic results of complex coronary lesions.
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Exclusion Criteria:
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
Also known as: sirolimus-eluting stent made in China
cumulative MACE (including cardiac death, non-fatal myocardial infarction and target lesion revascularization)
Time frame: 3 years
angiographic binary restenosis
Time frame: 8 months
late loss
Time frame: 8 months
cumulative target vessel revascularization
Time frame: 3 years
cumulative in-stent thrombosis
Time frame: 3 years
cumulative stroke
Time frame: 3 years
This study is status unknown, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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