ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Long Term Efficacy and Safety of Firebird Sirolimus-Eluting Stent In Complex Coronary Lesions (FIREMAN)

This study is enrolling participants by invitation only.

Sponsors and Collaborators: Xijing Hospital
Fourth Military Medical University
core laboratory of Cardiovascular Institute & Fuwai Hospital
MicroPort Medical (Shanghai) Co. Ltd.
Beijing CCheart Consulting Co.Ltd.
Information provided by: Xijing Hospital
ClinicalTrials.gov Identifier: NCT00552656
  Purpose

The purpose of this study is to investigate the long term efficacy and safety of firebird sirolimus-eluting stent for treatment of complex coronary Lesions.


Condition Intervention
Coronary Disease
Device: Firebird(TM) Sirolimus-Eluting Stent

ChemIDplus related topics:   Sirolimus   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Prospective, Multicenter Study of Firebird Sirolimus-Eluting Stent for Treatment of Complex Coronary Lesions. Clinical and Angiographic Outcomes of FIREMAN Study

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • cumulative MACE (including cardiac death, non-fatal myocardial infarction and target lesion revascularization) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • angiographic binary restenosis [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • late loss [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • cumulative target vessel revascularization [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • cumulative in-stent thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • cumulative stroke [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   1000
Study Start Date:   January 2007
Estimated Study Completion Date:   August 2010

Groups/Cohorts Assigned Interventions
1
the group of patients with angiographic results of complex coronary lesions(refer to the definition of protocol)are enrolled and given a clinical follow up and angiographic follow up during the following one year.
Device: Firebird(TM) Sirolimus-Eluting Stent
balloon expandable stent that made of stainless steel.The length is from 13mm-33mm,and the diameter from 2.5mm-4.0mm

Detailed Description:

Randomized clinical trials and large-scale registry studies have shown that sirolimus-eluting stents (SESs) decrease major adverse cardiovascular event(MACE)and restenosis rates compared with bare metal stents (BMSs), but relatively small proportion of patients of complex lesions were enrolled in these studies. Moreover,with the increase in complexity of lesions, different DES shows different effects. The long term effects of DES for treatment of complex coronary lesions remains to be established. This study aims to investigate the long term efficacy and safety of Firebird sirolimus-eluting stent implantation in a high-risk population, that is, the patients who had complex coronary lesions, including multivessel diseases,diffuse long lesions, left main lesions, chronic total occlusion, bifurcation lesions, small vessel diseases,severe calcification or angulation lesions, ostial lesions, restenotic lesions after bare metel stent implantation .

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

the study enrolls a group of high risk population who have angiographic results of complex coronary lesions.


Criteria

Inclusion Criteria:

  • the patients who have the indication for coronary interventional therapy
  • stable angina pectoris (CCS class I II III IV)or unstable angina pectoris (Braunwald class B&C,I-II) or documented asymptomatic myocardial ischemia
  • reference vessel diameter is of 2.5mm to 4.0mm (estimated by investigator)
  • significant(>70%) stenosis of target lesion (estimated by investigator)
  • angiographic criteria is complex coronary lesions which includes the followings: multivessel lesions(>or=two vessels), diffuse long lesions with length>or=30mm or need two stents overlapped, small vessel lesions(reference vessel diameter<or=2.5mm estimated by investigator), bifurcation lesions need one or two stents and side branch diameter>2.0mm, chronic total occlusion lesions(>3 months), ostial target lesions(including ostial of right coronary artery,left anterior descending artery and left circumflex artery), severe calcification or angulation(location of target lesion at a >45°bend), protected and unprotected left main lesions, restenosis after bare metal stent implantation(core laboratory decision )
  • the patients would like to accept the follow-up and sign the informed consent

Exclusion Criteria:

  • pregnant or nursing women
  • acute myocardial infarction within the preceding one month
  • graft lesions after CABG
  • implanted other drug-eluting stents at the same time except the designated one
  • left ventricle dysfunction with ejection fraction<30%(evaluated by echocardiogram with Simpson's double-chamber method)
  • renal dysfunction with serum creatinine level>or=2mg/dl(177umol/L)
  • pre-intervention with intravascular brachytherapy or other non-PTCA techniques
  • contradictions or allergy to aspirin, heparin, clopidogrel,stainless steel and hypersensitive to contrast media
  • anticipated life span < 12 months
  • enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552656

Locations
China, Shannxi
Department of Cardiology of Xijing Hospital, Fourth Military Medical University    
      Xi'an, Shannxi, China, 710032

Sponsors and Collaborators
Xijing Hospital
Fourth Military Medical University
core laboratory of Cardiovascular Institute & Fuwai Hospital
MicroPort Medical (Shanghai) Co. Ltd.
Beijing CCheart Consulting Co.Ltd.

Investigators
Principal Investigator:     Haichang Wang, MD,PhD     Director of Department of Cardiology of Xijing Hospital, Fourth Military Medical University    
  More Information


Publications:

Responsible Party:   Xijing Hospital of Fourth Military Military Medical University ( Haichang Wang / Director of Department of Cardiology of Xijing Hospital )
Study ID Numbers:   XJ-20060914
First Received:   October 31, 2007
Last Updated:   August 11, 2008
ClinicalTrials.gov Identifier:   NCT00552656
Health Authority:   China: State Food and Drug Administration

Keywords provided by Xijing Hospital:
Angioplasty, Transluminal, Percutaneous Coronary  
Drug-eluting stents  
Treatment Outcome  

Study placed in the following topic categories:
Sirolimus
Coronary Disease
Heart Diseases
Clotrimazole
Miconazole
Myocardial Ischemia
Tioconazole
Vascular Diseases
Ischemia

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




Links to all studies - primarily for crawlers