Efficacy and Safety of Firebird 2 Stent in Treatment of Complex Coronary Lesions in Diabetes
NCT ID: NCT01257373
Last Updated: 2010-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1300 participants
OBSERVATIONAL
2010-04-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent
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.
Interventions
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Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent
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.
Eligibility Criteria
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Inclusion Criteria
* The coronary lesion is complied with the definition of complex type. (defined by protocol)
* The investigator admitted patients which are suitable for implanting Firebird2 CoCr-alloyed Sirolimus-eluting stent(SES)
* Patient or his/ her legal supervisor are provided with informed consents.
Exclusion Criteria
* ST-segment elevated MI occurred within 1 week;
* Graft lesion after the coronary artery bypass graft(CABG) operation;
* Patient with other brand of stent implanted;
* LVEF ≤ 35%;
* Renal insufficiency before operation (Serum creatinine ≥ 177umol/L)
* Impaired fasting glucose（6.0mmol/L～7.0mmol/L）or impaired glucose tolerance（OGTT 2h blood glucose 7.8mmol/L～11.1mmol/L）patient;
* Recent PCI within 6 months or previous intravascular radiotherapy;
* Predicted life span is less than 12 months;
* Patient allergic to the following materials: aspirin, heparin, Clopidogrel, CoCr alloy, contrast agent or sirolimus.
* Recent participation of trial medication or other device study without endpoints completion or it is clinically interfering FIRE2-DIABETES study endpoints.
* Considered by other investigators unsuitable for implanting Firebird2 CoCr-alloyed SES
* Patients could not obey the study rules, such as not understanding the study manner, scope or its outcome, not cooperative, not providing the informed consent, not accepting follow-up, not finishing the whole study procedure.
18 Years
ALL
No
Sponsors
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Air Force Military Medical University, China
OTHER
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Shanghai MicroPort Medical (Group) Co., Ltd.
INDUSTRY
CCheart Consulting Co., Ltd.
INDUSTRY
Xijing Hospital
OTHER
Responsible Party
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Department of Cardiology of Xijing Hospital , Fourth Military Medical University
Principal Investigators
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Haichang Wang, MD，PhD
Role: PRINCIPAL_INVESTIGATOR
Department of cardiology of Xijing Hospital, Fourth Military Medcical Univercsity
Locations
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Department of cardiology of Xijing Hospital, Fourth Military Medical University
Xi'an, Shannxi, China
Countries
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Central Contacts
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Facility Contacts
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Haichang Wang, MD,PhD
Role: primary
Other Identifiers
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XJ-2010-01
Identifier Type: -
Identifier Source: org_study_id