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Long Term Efficacy and Safety of Firebird Sirolimus-Eluting Stent In Complex Coronary Lesions (FIREMAN)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Xijing Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00552656
First Posted: November 2, 2007
Last Update Posted: August 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fourth Military Medical University
core laboratory of Cardiovascular Institute & Fuwai Hospital
Shanghai MicroPort Medical (Group) Co., Ltd.
CCheart Consulting Co., Ltd.
Information provided by:
Xijing Hospital
  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

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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • angiographic binary restenosis [ Time Frame: 8 months ]
  • late loss [ Time Frame: 8 months ]
  • cumulative target vessel revascularization [ Time Frame: 3 years ]
  • cumulative in-stent thrombosis [ Time Frame: 3 years ]
  • cumulative stroke [ Time Frame: 3 years ]

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
Other Name: sirolimus-eluting stent made in China

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Shanghai MicroPort Medical (Group) Co., Ltd.
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Haichang Wang / Director of Department of Cardiology of Xijing Hospital, Xijing Hospital of Fourth Military Military Medical University
ClinicalTrials.gov Identifier: NCT00552656     History of Changes
Other Study ID Numbers: XJ-20060914
First Submitted: October 31, 2007
First Posted: November 2, 2007
Last Update Posted: August 12, 2008
Last Verified: August 2008

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

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs