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DXR Stent(Previous Cilotax) Implantation Registry

Sponsor
Seung-Jung Park (Other)
Overall Status
Terminated
CT.gov ID
NCT01612819
Collaborator
CardioVascular Research Foundation, Korea (Other), Cardiotec Corporation (Industry)
451
Enrollment
18
Locations
59.9
Actual Duration (Months)
25.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Registry of cilotax stent(Dual drug eluting stent) implantation for CAD patients

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    451 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Effectiveness and Safety of DXR(Previous Cilotax) Stent in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-CILOTAX)
    Actual Study Start Date :
    Apr 1, 2012
    Actual Primary Completion Date :
    Mar 30, 2017
    Actual Study Completion Date :
    Mar 30, 2017

    Outcome Measures

    Primary Outcome Measures

    1. composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) [at 12 months post procedure]

    Secondary Outcome Measures

    1. Death (all cause and cardiac) [one month]

    2. Death (all cause and cardiac) [6 months]

    3. Death (all cause and cardiac) [12 months and yearly up to 5 years]

    4. Myocardial Infarction [12 months and yearly up to 5 years]

    5. Myocardial Infarction [one month]

    6. Myocardial Infarction [6 months]

    7. Composite of death or MI [6 months]

    8. Composite of death or MI [one month]

    9. Composite of death or MI [12 months and yearly upto 5 years]

    10. Composite of cardiac death or MI [one month]

    11. Composite of cardiac death or MI [6 months]

    12. Composite of cardiac death or MI [12 months and yearly up to 5 years]

    13. Target Vessel Revascularization [12 months and yearly up to 5 years]

    14. Target Vessel Revascularization [one month]

    15. Target Vessel Revascularization [6 months]

    16. Target-lesion revascularization [one month]

    17. Target-lesion revascularization [6 months]

    18. Target-lesion revascularization [12 months and yearly up to 5 years]

    19. Stent thrombosis [12 months and yearly up to 5 years]

    20. Stent thrombosis [one month]

    21. Stent thrombosis [6 months]

    22. Procedural success [at day 1]

      It is defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with significant coronary artery disease and receiving Cilotax (dual drug eluting stent)

    • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site

    Exclusion Criteria:

    • Patients with a mixture of other DESs

    • Terminal illness with life expectancy <1 year

    • Patients presented with cardiogenic shock

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Soonchunhyang University Hospital, Buchen Bucheon Korea, Republic of
    2 Dankook University Hospital Cheonan Korea, Republic of
    3 Kangwon National University Hospital Chuncheon Korea, Republic of
    4 Daegu Catholic University Medical Center Daegu Korea, Republic of
    5 Keimyung University Dongsan Medical Center Daegu Korea, Republic of
    6 Yeungnam University Medical Center Daegu Korea, Republic of
    7 Daejeon St. Mary's Hospital, The Catholic University of Korea Daejeon Korea, Republic of
    8 GangNeung Asan Hospital Gangneung Korea, Republic of
    9 Gwangju Veterans Hospital Gwangju Korea, Republic of
    10 Kwangju Christian Hospital Gwangju Korea, Republic of
    11 Dongguk university gyeongju hospital Gyeongju Korea, Republic of
    12 Hallym University Dongtan Sacred Heart Hospital Hwasong Korea, Republic of
    13 Asan Medical Center Seoul Korea, Republic of
    14 Gangnam Severance Hospital Seoul Korea, Republic of
    15 Korea University Guro Hospital Seoul Korea, Republic of
    16 Seoul St. Mary's Hospital, The Catholic University of Korea Seoul Korea, Republic of
    17 ST.Carollo Hospital Suncheon Korea, Republic of
    18 Ulsan University Hospital Ulsan Korea, Republic of

    Sponsors and Collaborators

    • Seung-Jung Park
    • CardioVascular Research Foundation, Korea
    • Cardiotec Corporation

    Investigators

    • Principal Investigator: Ki Bae Seung, MD, PhD, Seoul St. Mary's Hospital, Catholic University of Korea
    • Principal Investigator: Seung-Jung Park, MD, PhD, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seung-Jung Park, MD, PhD, CardioVascular Research Foundation, Korea
    ClinicalTrials.gov Identifier:
    NCT01612819
    Other Study ID Numbers:
    • CVRF2012-01
    First Posted:
    Jun 6, 2012
    Last Update Posted:
    Mar 31, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Mar 31, 2017