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

NCT00552656 | Unknown DMC

• 1 other identifier: XJ-20060914
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (5)

• angiographic binary restenosis

  8 months

• late loss

  8 months

• cumulative target vessel revascularization

  3 years

• cumulative in-stent thrombosis

  3 years

• cumulative stroke

  3 years

Study Arms (1)

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

Interventions

Firebird(TM) Sirolimus-Eluting Stent DEVICE

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

Also known as: sirolimus-eluting stent made in China

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead
• Air Force Military Medical University, China: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Shanghai MicroPort Medical (Group) Co., Ltd.: collaborator
• CCheart Consulting Co., Ltd.: collaborator

Study Sites (1)

Department of Cardiology of Xijing Hospital, Fourth Military Medical University

Xi'an, Shannxi, 710032, China

Location

Related Publications (2)

• 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.

  PMID: 14993127 BACKGROUND

• 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.

  PMID: 21518586 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Haichang Wang, MD,PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 2, 2007
• Study Start: January 1, 2007
• Study Completion: August 1, 2010
• Last Updated: August 12, 2008

Record last verified: 2008-08

Locations

CN (1)