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

NCT01257373 | Unknown DMC

• 1 other identifier: XJ-2010-01
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Cumulative major adverse cardiovascular events（MACE）

  including cardiac death, Q-wave or Non-Q-wave MI,ischemia driven Target Lesion Revascularization (TLR)

  12-month

Secondary Outcomes (4)

• Post-procedure MACE

  30 days, 6/12/18/24/30/36 months.

• Cumulative stent thrombosis

  12 months

• Ischemia-driven target vessel revascularization(TVR)

  12 months

• Stroke

  12 months

Study Arms (1)

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.

Device: Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent

Interventions

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.

patiens with Firebird 2 stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead
• Air Force Military Medical University, China: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Shanghai MicroPort Medical (Group) Co., Ltd.: collaborator
• CCheart Consulting Co., Ltd.: collaborator

Study Sites (1)

Department of cardiology of Xijing Hospital, Fourth Military Medical University

Xi'an, Shannxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Haichang Wang, MD，PhD

  Department of cardiology of Xijing Hospital, Fourth Military Medcical Univercsity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haichang Wang, MD,PhD

CONTACT

86-2984775183; wanghc@fmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 9, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2013
• Last Updated: December 30, 2010

Record last verified: 2009-11

Locations

CN (1)