Long Term Efficacy and Safety of Firebird Sirolimus-Eluting Stent In Complex Coronary Lesions (FIREMAN)
This study is enrolling participants by invitation only.
Sponsor:
Xijing Hospital
Collaborators:
Fourth Military Medical University
core laboratory of Cardiovascular Institute & Fuwai Hospital
MicroPort Medical (Shanghai) Co. Ltd.
Beijing CCheart Consulting Co.Ltd.
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00552656
First received: October 31, 2007
Last updated: August 11, 2008
Last verified: August 2008
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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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- angiographic binary restenosis [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- late loss [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- cumulative target vessel revascularization [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- cumulative in-stent thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- cumulative stroke [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| 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| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
MicroPort Medical (Shanghai) Co. Ltd.
Beijing 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:
Additional 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 |
| Study First Received: | October 31, 2007 |
| Last Updated: | August 11, 2008 |
| Health Authority: | China: Food and Drug Administration |
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 |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 18, 2013