A Single Center Prospective Randomized Controlled Clinical Study of JANUS Stent in Patients With Coronary Artery Disease
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|ClinicalTrials.gov Identifier: NCT00406523|
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : December 4, 2006
Janus stent is the only marketed drug-eluting stent (DES) without polymer coating as yet in China. The goal of this study is to evaluate the efficacy of JANUS (Tacrolimus eluted stent) in inhibiting of restenosis in percutaneous coronary intervention (PCI) real world and to observe the safety and efficacy of 4 months’clopidogrel treatment after implantation of JANUS stent.
Patients were enrolled and randomized to be treated by JANUS or SRNCRO (bare metal stent with the same platform as JANUS). All enrolled patients received daily clopidogrel for 4 months and aspirin for life long for post-PCI period(In AMI group, patients received daily clopidogrel 150mg for 2 weeks at first). The primary endpoints included death of heart, myocardial infarction, revascularization of the target lesson, sub-acute and late stent thrombosis one year after PCI, The secondary endpoints included MACE at 30 days, 6 months and restenosis by follow-up angiogram at 6 to 12 months.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease||Device: JANUS Stent||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2006|
|Study Completion Date :||September 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406523
|Principal Investigator:||Yaling Han, M.D.||Shenyang Northern Hospital|