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Sponsors and Collaborators: |
Xijing Hospital Fourth Military Medical University core laboratory of Cardiovascular Institute & Fuwai Hospital MicroPort Medical (Shanghai) Co. Ltd. Beijing CCheart Consulting Co.Ltd. |
Information provided by: | Xijing Hospital |
ClinicalTrials.gov Identifier: | NCT00552656 |
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 | Intervention |
Coronary Disease |
Device: Firebird(TM) Sirolimus-Eluting Stent |
ChemIDplus related topics: | Sirolimus |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Prospective, Multicenter Study of Firebird Sirolimus-Eluting Stent for Treatment of Complex Coronary Lesions. Clinical and Angiographic Outcomes of FIREMAN Study |
Estimated Enrollment: | 1000 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | August 2010 |
Groups/Cohorts | Assigned Interventions |
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.
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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
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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 .
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
the study enrolls a group of high risk population who have angiographic results of complex coronary lesions.
Inclusion Criteria:
Exclusion Criteria:
China, Shannxi | |||||
Department of Cardiology of Xijing Hospital, Fourth Military Medical University | |||||
Xi'an, Shannxi, China, 710032 |
Xijing Hospital |
Fourth Military Medical University |
core laboratory of Cardiovascular Institute & Fuwai Hospital |
MicroPort Medical (Shanghai) Co. Ltd. |
Beijing CCheart Consulting Co.Ltd. |
Principal Investigator: | Haichang Wang, MD,PhD | Director of Department of Cardiology of Xijing Hospital, Fourth Military Medical University |
Responsible Party: | Xijing Hospital of Fourth Military Military Medical University ( Haichang Wang / Director of Department of Cardiology of Xijing Hospital ) |
Study ID Numbers: | XJ-20060914 |
First Received: | October 31, 2007 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00552656 |
Health Authority: | China: State Food and Drug Administration |
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