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| Name | Class |
|---|---|
| Air Force Military Medical University, China | OTHER |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Shanghai MicroPort Medical (Group) Co., Ltd. | INDUSTRY |
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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firebird(TM) Sirolimus-Eluting Stent | Device | balloon expandable stent that made of stainless steel.The length is from 13mm-33mm,and the diameter from 2.5mm-4.0mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| cumulative MACE (including cardiac death, non-fatal myocardial infarction and target lesion revascularization) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| angiographic binary restenosis | 8 months | |
| late loss | 8 months | |
| cumulative target vessel revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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the study enrolls a group of high risk population who have angiographic results of complex coronary lesions.
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| Name | Affiliation | Role |
|---|---|---|
| Haichang Wang, MD,PhD | Director of Department of Cardiology of Xijing Hospital, Fourth Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology of Xijing Hospital, Fourth Military Medical University | Xi'an | Shannxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14993127 | Background | 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. | |
| 21518586 |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| CCheart Consulting Co., Ltd. |
| INDUSTRY |
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|
| 3 years |
| cumulative in-stent thrombosis | 3 years |
| cumulative stroke | 3 years |
| Derived |
| 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. |