Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease
NCT ID: NCT01373632
Last Updated: 2011-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
570 participants
INTERVENTIONAL
2011-06-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Firebird 2 stent group
the patients who receive Firebird 2 stent
Firebird 2 sirolimus-eluting stent
the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform
Excel stent group
the patients who receive Excel stent
Excel sirolimus-eluting stent
the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform
Interventions
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Firebird 2 sirolimus-eluting stent
the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform
Excel sirolimus-eluting stent
the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform
Eligibility Criteria
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Inclusion Criteria
* male or un-pregnant female
* stenosis \> 70% in one of major the epicardial coronary arteries
* no contra-indications of stent implantation
* singed the informed consent
Exclusion Criteria
* have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy
* no history of stent implantation within last one-year
* received other brand coronary stent during index procedure
* with no achievement of informed consent
18 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Cardiovascular Department
Locations
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Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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Xian Zhang, MD
Role: backup
References
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Zhang Q, Xu B, Yang YJ, Zhang RY, Li JP, Qiao SB, Zhang JS, Hu J, Qin XW, Hong T, Chen JL, Huo Y, Shen WF, Gao RL. Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result. A prospective, historically controlled, multi-center clinical study. Chin Med J (Engl). 2007 Apr 5;120(7):533-8.
Han Y, Jing Q, Chen X, Wang S, Ma Y, Liu H, Luan B, Wang G, Li Y, Wang Z, Wang D, Xu B, Gao R. Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents. Catheter Cardiovasc Interv. 2008 Aug 1;72(2):177-83. doi: 10.1002/ccd.21600.
Other Identifiers
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20110611
Identifier Type: -
Identifier Source: org_study_id
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