Efficacy and Safety of Firebird 2 Stent in Treatment of Complex Coronary Lesions in Diabetes

Coronary Artery Disease Clinical Trial

Official title:

Efficacy and Safety of Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent in Treatment of Complex Coronary Lesions in Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01257373
• Other study ID #: XJ-2010-01
• Status: Recruiting
• Phase: Phase 4
• First received: December 2, 2010
• Last updated: December 28, 2010
• Start date: April 2010
• Est. completion date: April 2013

Study information

• Verified date: November 2009
• Source: Xijing Hospital
• Contact: Haichang Wang, MD,PhD
• Phone: 86-2984775183
• Email: wanghc[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: April 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Department of cardiology of Xijing Hospital, Fourth Military Medical University	Xi'an	Shannxi

Sponsors (5)

Lead Sponsor	Collaborator
Xijing Hospital	CCheart Consulting Co., Ltd., Chinese Academy of Medical Sciences, Fuwai Hospital, Fourth Military Medical University, Shanghai MicroPort Medical (Group) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative major adverse cardiovascular events(MACE)	including cardiac death, Q-wave or Non-Q-wave MI,ischemia driven Target Lesion Revascularization (TLR)	12-month	Yes
Secondary	Post-procedure MACE		30 days, 6/12/18/24/30/36 months.	Yes
Secondary	Cumulative stent thrombosis	By Academic Research Consortium(ARC) definition (definite and probable)	12 months	Yes
Secondary	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	No
Secondary	Stroke	including Ischemic and hemorrhagic stroke	12 months	Yes