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

August 11, 2008 updated by: Xijing Hospital

Prospective, Multicenter Study of Firebird Sirolimus-Eluting Stent for Treatment of Complex Coronary Lesions. Clinical and Angiographic Outcomes of FIREMAN Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 .

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • sirolimus-eluting stent made in China

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cumulative MACE (including cardiac death, non-fatal myocardial infarction and target lesion revascularization)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
angiographic binary restenosis
Time Frame: 8 months
8 months
late loss
Time Frame: 8 months
8 months
cumulative target vessel revascularization
Time Frame: 3 years
3 years
cumulative in-stent thrombosis
Time Frame: 3 years
3 years
cumulative stroke
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Air Force Military Medical University, China
Shanghai MicroPort Medical (Group) Co., Ltd.
CCheart Consulting Co., Ltd.
core laboratory of Cardiovascular Institute & Fuwai Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

October 31, 2007

First Submitted That Met QC Criteria

October 31, 2007

First Posted (Estimate)

November 2, 2007

Study Record Updates

Last Update Posted (Estimate)

August 12, 2008

Last Update Submitted That Met QC Criteria

August 11, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJ-20060914

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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