MedDataX Logo

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

NCT ID: NCT00552656

Last Updated: 2008-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Angioplasty, Transluminal, Percutaneous Coronary Drug-eluting stents Treatment Outcome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Firebird(TM) Sirolimus-Eluting Stent

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

sirolimus-eluting stent made in China

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

Shanghai MicroPort Medical (Group) Co., Ltd.

INDUSTRY

Sponsor Role collaborator

CCheart Consulting Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xijing Hospital of Fourth Military Military Medical University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Haichang Wang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Cardiology of Xijing Hospital, Fourth Military Medical University

Xi'an, Shannxi, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 14993127 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21518586 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XJ-20060914

Identifier Type: -

Identifier Source: org_study_id