- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01612819
DXR Stent(Previous Cilotax) Implantation Registry
March 30, 2017 updated by: Seung-Jung Park
Evaluation of Effectiveness and Safety of DXR(Previous Cilotax) Stent in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-CILOTAX)
Registry of cilotax stent(Dual drug eluting stent) implantation for CAD patients
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
451
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bucheon, Korea, Republic of
- Soonchunhyang University Hospital, Buchen
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Cheonan, Korea, Republic of
- Dankook University Hospital
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Chuncheon, Korea, Republic of
- Kangwon National University Hospital
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Daegu, Korea, Republic of
- Daegu Catholic University Medical Center
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Daegu, Korea, Republic of
- Keimyung University Dongsan Medical Center
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Daegu, Korea, Republic of
- Yeungnam University Medical Center
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Daejeon, Korea, Republic of
- Daejeon St. Mary's Hospital, the Catholic University of Korea
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Gangneung, Korea, Republic of
- Gangneung Asan Hospital
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Gwangju, Korea, Republic of
- Kwangju Christian Hospital
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Gwangju, Korea, Republic of
- Gwangju Veterans Hospital
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Gyeongju, Korea, Republic of
- Dongguk university gyeongju hospital
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Hwasong, Korea, Republic of
- Hallym University Dongtan Sacred Heart Hospital
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Seoul, Korea, Republic of
- Asan Medical Center
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Seoul, Korea, Republic of
- Gangnam Severance Hospital
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Seoul, Korea, Republic of
- Korea University Guro Hospital
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Seoul, Korea, Republic of
- Seoul St. Mary's Hospital, The Catholic University of Korea
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Suncheon, Korea, Republic of
- St.Carollo Hospital
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Ulsan, Korea, Republic of
- Ulsan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with coronary artery disease requiring drug eluting stents
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
Time Frame: at 12 months post procedure
|
at 12 months post procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death (all cause and cardiac)
Time Frame: 6 months
|
6 months
|
|
Composite of death or MI
Time Frame: 6 months
|
6 months
|
|
Composite of cardiac death or MI
Time Frame: 6 months
|
6 months
|
|
Target Vessel Revascularization
Time Frame: 6 months
|
6 months
|
|
Stent thrombosis
Time Frame: 6 months
|
6 months
|
|
Composite of death or MI
Time Frame: one month
|
one month
|
|
Composite of cardiac death or MI
Time Frame: one month
|
one month
|
|
Myocardial Infarction
Time Frame: 6 months
|
6 months
|
|
Death (all cause and cardiac)
Time Frame: one month
|
one month
|
|
Death (all cause and cardiac)
Time Frame: 12 months and yearly up to 5 years
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12 months and yearly up to 5 years
|
|
Myocardial Infarction
Time Frame: 12 months and yearly up to 5 years
|
12 months and yearly up to 5 years
|
|
Myocardial Infarction
Time Frame: one month
|
one month
|
|
Composite of death or MI
Time Frame: 12 months and yearly upto 5 years
|
12 months and yearly upto 5 years
|
|
Composite of cardiac death or MI
Time Frame: 12 months and yearly up to 5 years
|
12 months and yearly up to 5 years
|
|
Target Vessel Revascularization
Time Frame: 12 months and yearly up to 5 years
|
12 months and yearly up to 5 years
|
|
Target Vessel Revascularization
Time Frame: one month
|
one month
|
|
Target-lesion revascularization
Time Frame: one month
|
one month
|
|
Target-lesion revascularization
Time Frame: 6 months
|
6 months
|
|
Target-lesion revascularization
Time Frame: 12 months and yearly up to 5 years
|
12 months and yearly up to 5 years
|
|
Stent thrombosis
Time Frame: 12 months and yearly up to 5 years
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12 months and yearly up to 5 years
|
|
Stent thrombosis
Time Frame: one month
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one month
|
|
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.
|
at day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2012
Primary Completion (ACTUAL)
March 30, 2017
Study Completion (ACTUAL)
March 30, 2017
Study Registration Dates
First Submitted
June 1, 2012
First Submitted That Met QC Criteria
June 4, 2012
First Posted (ESTIMATE)
June 6, 2012
Study Record Updates
Last Update Posted (ACTUAL)
March 31, 2017
Last Update Submitted That Met QC Criteria
March 30, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVRF2012-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is not a publicly funded trial.
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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