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DXR Stent(Previous Cilotax) Implantation Registry

This study has been terminated.
(No more enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01612819
First Posted: June 6, 2012
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
CardioVascular Research Foundation, Korea
Cardiotec Corporation
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
  Purpose
Registry of cilotax stent(Dual drug eluting stent) implantation for CAD patients

Condition
Coronary Artery Diseases

Study Type: Observational
Study Design: 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)

Further study details as provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:

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

Secondary Outcome 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.


Enrollment: 451
Actual Study Start Date: April 2012
Study Completion Date: March 30, 2017
Primary Completion Date: March 30, 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with coronary artery disease requiring drug eluting stents
Criteria

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
Information from the National Library of Medicine

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): NCT01612819


Locations
Korea, Republic of
Soonchunhyang University Hospital, Buchen
Bucheon, Korea, Republic of
Dankook University Hospital
Cheonan, Korea, Republic of
Kangwon National University Hospital
Chuncheon, Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Yeungnam University Medical Center
Daegu, Korea, Republic of
Daejeon St. Mary's Hospital, The Catholic University of Korea
Daejeon, Korea, Republic of
GangNeung Asan Hospital
Gangneung, Korea, Republic of
Gwangju Veterans Hospital
Gwangju, Korea, Republic of
Kwangju Christian Hospital
Gwangju, Korea, Republic of
Dongguk university gyeongju hospital
Gyeongju, Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital
Hwasong, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of
ST.Carollo Hospital
Suncheon, Korea, Republic of
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
  More Information

Responsible Party: Seung-Jung Park, MD, PhD, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01612819     History of Changes
Other Study ID Numbers: CVRF2012-01
First Submitted: June 1, 2012
First Posted: June 6, 2012
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases