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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 goal of this study is to assess the long-term efficacy and safety of Firebird2 Cobalt-Chromium(CoCr)-alloyed sirolimus-eluting stent in treatment of complex lesions in diabetes.
This clinical trial is an international multi-center prospective clinical registry research, for evaluating the efficacy and safety of Firebird 2 cobalt-chromium alloyed sirolimus-eluting stent in treatment of complex coronary lesions in diabetes. As planned, about 57 research centers all over China, Latin America and Asia-Pacific areas will be involved and, 1300 patients will be enrolled into this research. The implanted stents must all be Firebird2 cobalt-chromium alloyed sirolimus-eluting stent. The patient enrollment will last for 12 months. Clinical follow-up will be done respectively for 30 days, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months. All quitted patients during the study will not be replaced with any substitutes, but categorized in the enrollment failure column. The researcher must state clear the reason of nonenrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patiens with Firebird 2 stent | The group of 1300 patients, in which only Fireibrd2 stent is implanted, will be collected. All inclusive patients should be definitely diagnosed type 2 diabetic mellitus (DM), either before or during the present hospitalization and with complex coronary lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent | Device | Firebird2 CoCr-alloyed sirolimus-eluting stent system is the 2nd generation of drug-eluting stent(DES). It was registered successfully on Jan. 16, 2009 in China. This stent is based with a CoCr alloyed metal platform. The length is from 13-33mm, the diameter is from 2.5mm-4.0mm. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative major adverse cardiovascular events(MACE) | including cardiac death, Q-wave or Non-Q-wave MI,ischemia driven Target Lesion Revascularization (TLR) | 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedure MACE | 30 days, 6/12/18/24/30/36 months. | |
| Cumulative stent thrombosis | By Academic Research Consortium(ARC) definition (definite and probable) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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This registry study will be conducted in 56 centers in which Firebird 2 stent is implemented. The data of 1300 patients, in which only Fireibrd2 stent is implanted, will be collected. All inclusive patients should be definitely diagnosed type 2 DM, either before or during the present hospitalization and with complex coronary lesions. The diagnosis criteria is the World Health Organization(WHO) recommended criteria 1999 version. I.e., fasting blood glucose ≥7.0mmol/L,random blood glucose ≥11.1mmol/L,or OGTT 2h blood glucose ≥11.1mmol/L. Impaired fasting glucose (6.0mmol/L~7.0mmol/L) or Impaired glucose tolerance (oral glucose tolerance test(OGTT) 2h blood glucose 7.8mmol/L~11.1mmol/L) can not be enrolled. The stress-induced hyperglycemia of acute coronary syndrome is illegible.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haichang Wang, MD,PhD | Contact | 86-2984775183 | wanghc@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Haichang Wang, MD,PhD | Department of cardiology of Xijing Hospital, Fourth Military Medcical Univercsity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of cardiology of Xijing Hospital, Fourth Military Medical University | Recruiting | Xi'an | Shannxi | 710032 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| CCheart Consulting Co., Ltd. |
| INDUSTRY |
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|
| Ischemia-driven target vessel revascularization(TVR) | The repeated intervention therapy or surgical bypass grafting to any segment of the target vessel is called target vessel revascularization. Target vessel means the entire major coronary arteries proximal or distal to the target lesion, including all upstream and downstream branches and the lesion itself | 12 months |
| Stroke | including Ischemic and hemorrhagic stroke | 12 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |