DXR Stent(Previous Cilotax) Implantation Registry

Overview

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

Full Title of Study: “Evaluation of Effectiveness and Safety of DXR(Previous Cilotax) Stent in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-CILOTAX)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 30, 2017

Clinical Trial Outcome Measures

Primary Measures

  • composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
    • Time Frame: at 12 months post procedure

Secondary Measures

  • Death (all cause and cardiac)
    • Time Frame: one month
  • Death (all cause and cardiac)
    • Time Frame: 6 months
  • Death (all cause and cardiac)
    • Time Frame: 12 months and yearly up to 5 years
  • Myocardial Infarction
    • Time Frame: 12 months and yearly up to 5 years
  • Myocardial Infarction
    • Time Frame: one month
  • Myocardial Infarction
    • Time Frame: 6 months
  • Composite of death or MI
    • Time Frame: 6 months
  • Composite of death or MI
    • Time Frame: one month
  • Composite of death or MI
    • Time Frame: 12 months and yearly upto 5 years
  • Composite of cardiac death or MI
    • Time Frame: one month
  • Composite of cardiac death or MI
    • Time Frame: 6 months
  • Composite of cardiac death or MI
    • Time Frame: 12 months and yearly up to 5 years
  • Target Vessel Revascularization
    • Time Frame: 12 months and yearly up to 5 years
  • Target Vessel Revascularization
    • Time Frame: one month
  • Target Vessel Revascularization
    • Time Frame: 6 months
  • Target-lesion revascularization
    • Time Frame: one month
  • Target-lesion revascularization
    • Time Frame: 6 months
  • Target-lesion revascularization
    • Time Frame: 12 months and yearly up to 5 years
  • Stent thrombosis
    • Time Frame: 12 months and yearly up to 5 years
  • Stent thrombosis
    • Time Frame: one month
  • Stent thrombosis
    • Time Frame: 6 months
  • Procedural success
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seung-Jung Park
  • Collaborator
    • CardioVascular Research Foundation, Korea
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Seung-Jung Park, MD, PhD – CardioVascular Research Foundation, Korea
  • Overall Official(s)
    • Ki Bae Seung, MD, PhD, Principal Investigator, Seoul St. Mary’s Hospital, Catholic University of Korea
    • Seung-Jung Park, MD, PhD, Principal Investigator, Asan Medical Center

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