Clinical trial NCT01257373: Efficacy and Safety of Firebird 2 Stent in Treatment of Complex Coronary Lesions in Diabetes
Official title: Efficacy and Safety of Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent in Treatment of Complex Coronary Lesions in Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shanghai MicroPort Medical (Group) Co., Ltd.
name: CCheart Consulting Co., Ltd.
First posted: 2010-12-09
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Definitely diagnosed type 2 DM either before or during the current hospitalization and with complex coronary lesions
* 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:

* Women during pregnancy and breast-feeding;
* 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.

Primary outcomes:
measure: Cumulative major adverse cardiovascular events（MACE）
timeFrame: 12-month
Secondary outcomes:
measure: Post-procedure MACE
timeFrame: 30 days, 6/12/18/24/30/36 months.
measure: Cumulative stent thrombosis
timeFrame: 12 months
measure: Ischemia-driven target vessel revascularization(TVR)
timeFrame: 12 months
measure: Stroke
timeFrame: 12 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of cardiology of Xijing Hospital, Fourth Military Medical University
state: Shannxi
Study officials:
affiliation: Department of cardiology of Xijing Hospital, Fourth Military Medcical Univercsity
name: Haichang Wang, MD，PhD
role: PRINCIPAL_INVESTIGATOR
References: