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A Single Center Prospective Randomized Controlled Clinical Study of JANUS Stent in Patients With Coronary Artery Disease

Sponsor
Shenyang Northern Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00406523
Collaborator
(none)
19
Duration (Months)

Study Details

Study Description

Brief Summary

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
  • Device: JANUS Stent
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Feb 1, 2006
Study Completion Date :
Sep 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shenyang Northern Hospital

    Investigators

    • Principal Investigator: Yaling Han, M.D., Shenyang Northern Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00406523
    Other Study ID Numbers:
    • NH-2006-B003
    First Posted:
    Dec 4, 2006
    Last Update Posted:
    Dec 4, 2006
    Last Verified:
    Nov 1, 2006
    Additional relevant MeSH terms:
    Heart Diseases
    Coronary Disease
    Coronary Artery Disease
    Myocardial Ischemia

    Study Results

    No Results Posted as of Dec 4, 2006