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Coronary DiseaseFIREMANNCT00552656

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

An observational study of Coronary Disease, run by Xijing Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronary Disease
What is being tested?
Firebird(TM) Sirolimus-Eluting Stent
Type of treatment
Medical device
How many people
1,000 participants
Where
1 siteChina
Study dates
Jan 2007to Aug 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Cardiology of Xijing Hospital, Fourth Military Medical University

    Xi'an, Shannxi, 710032

Other trials in China

About this study

Official title: 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.

Read the 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 .

Being tested
Firebird(TM) Sirolimus-Eluting Stent
Keywords
Angioplasty, Transluminal, Percutaneous Coronary, Drug-eluting stents, Treatment Outcome
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Firebird(TM) Sirolimus-Eluting StentDevice

    Also called sirolimus-eluting stent made in China

    balloon expandable stent that made of stainless steel.The length is from 13mm-33mm,and the diameter from 2.5mm-4.0mm

Study groups in NCT00552656
Study groupRoleWhat they receive
1the 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.
Receives: Device: Firebird(TM) Sirolimus-Eluting Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cumulative MACE (including cardiac death, non-fatal myocardial infarction and target lesion revascularization)

    Measured: 3 years

Secondary outcomes (5)

  1. angiographic binary restenosis

    Measured: 8 months

  2. late loss

    Measured: 8 months

  3. cumulative target vessel revascularization

    Measured: 3 years

  4. cumulative in-stent thrombosis

    Measured: 3 years

  5. cumulative stroke

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2007 (estimated)
  2. Study startJan 2007
  3. Study completionAug 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00552656
Sponsor's protocol ID
XJ-20060914
Acronym
FIREMAN
Status last verified
Aug 2008
First submitted
31 Oct 2007
Last updated
12 Aug 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Lemos PA, Hoye A, Goedhart D, Arampatzis CA, Saia F, van der Giessen WJ, McFadden E, Sianos G, Smits PC, Hofma SH, de Feyter PJ, van Domburg RT, Serruys PW. Clinical, angiographic, and procedural predictors of angiographic restenosis after sirolimus-eluting stent implantation in complex patients: an evaluation from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) study. Circulation. 2004 Mar 23;109(11):1366-70. doi: 10.1161/01.CIR.0000121358.26097.06. Epub 2004 Mar 1.

    PubMed 14993127

  • Li Y, Li CX, Wang HC, Xu B, Fang WY, Ge JB, Wang WM, Qiao SB, Chen JP, Shen WK, Jiang H, Cong HL, Pu XQ, Qin YW, Jin HG, Cao Y, Huang H. Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients: one-year clinical and eight-month angiographic outcomes from the FIREMAN registry. Chin Med J (Engl). 2011 Mar;124(6):817-24.

    PubMed 21518586

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Disease, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cumulative MACE (including cardiac death, non-fatal myocardial infarction and target lesion revascularization) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00552656, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2008.

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