- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00406523
A Single Center Prospective Randomized Controlled Clinical Study of JANUS Stent in Patients With Coronary Artery Disease
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.
Study Overview
Study Type
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who were eligible for coronary stenting
- All patients enrolled were implanted only one kind of stent
- Stent number ≤ 8 per patient and ≤3 per vessel (stents overlapping part for 3~5mm and being fully post-dilated; Total stent length ≤ 85mm in same vessel)
- Willing and able to sign informed consent.
Exclusion Criteria:
- Patients with multi-vessel disease could not be implanted the same kind of stent
- In-stent restenosis target lesion
- Patients not eligible for DES implantation (e.g. intolerance to anti-platelet therapy or undergoing heart or non-heart surgery recently
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yaling Han, M.D., Shenyang Northern Hospital
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NH-2006-B003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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