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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Fourth Military Medical University
Cardiovascular Institute & Fuwai Hospital
MicroPort Medical (Shanghai) Co. Ltd.
Beijing CCheart Consulting Co.Ltd.
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01257373
First received: December 2, 2010
Last updated: December 28, 2010
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy and Safety of Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent in Treatment of Complex Coronary Lesions in Diabetes

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Cumulative major adverse cardiovascular events(MACE) [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
    including cardiac death, Q-wave or Non-Q-wave MI,ischemia driven Target Lesion Revascularization (TLR)


Secondary Outcome Measures:
  • Post-procedure MACE [ Time Frame: 30 days, 6/12/18/24/30/36 months. ] [ Designated as safety issue: Yes ]
  • Cumulative stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    By Academic Research Consortium(ARC) definition (definite and probable)

  • Ischemia-driven target vessel revascularization(TVR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

  • Stroke [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    including Ischemic and hemorrhagic stroke


Estimated Enrollment: 1300
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257373

Contacts
Contact: Haichang Wang, MD,PhD 86-2984775183 wanghc@fmmu.edu.cn

Locations
China, Shannxi
Department of cardiology of Xijing Hospital, Fourth Military Medical University Recruiting
Xi'an, Shannxi, China, 710032
Contact: Haichang Wang, MD,PhD    86-2984775183    wanghc@fmmu.edu.cn   
Principal Investigator: Haichang Wang, MD,PhD         
Sub-Investigator: Yan Li, MD,PhD         
Sub-Investigator: Chengxiang Li, MD,PhD         
Sponsors and Collaborators
Xijing Hospital
Fourth Military Medical University
Cardiovascular Institute & Fuwai Hospital
MicroPort Medical (Shanghai) Co. Ltd.
Beijing CCheart Consulting Co.Ltd.
Investigators
Principal Investigator: Haichang Wang, MD,PhD Department of cardiology of Xijing Hospital, Fourth Military Medcical Univercsity
  More Information

No publications provided

Responsible Party: Wang Haichang, Department of Cardiology of Xijing Hospital , Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01257373     History of Changes
Other Study ID Numbers: XJ-2010-01
Study First Received: December 2, 2010
Last Updated: December 28, 2010
Health Authority: China: National Natural Science Foundation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chromium
Cobalt
Sirolimus
Everolimus
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 14, 2014