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

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

      • Bucheon, Korea, Republic of
        • Soonchunhyang University Hospital, Buchen
      • Cheonan, Korea, Republic of
        • Dankook University Hospital
      • Chuncheon, Korea, Republic of
        • Kangwon National University Hospital
      • Daegu, 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
      • Daejeon, Korea, Republic of
        • Daejeon St. Mary's Hospital, the Catholic University of Korea
      • Gangneung, Korea, Republic of
        • Gangneung Asan Hospital
      • Gwangju, Korea, Republic of
        • Kwangju Christian Hospital
      • Gwangju, Korea, Republic of
        • Gwangju Veterans Hospital
      • Gyeongju, Korea, Republic of
        • Dongguk university gyeongju hospital
      • Hwasong, Korea, Republic of
        • Hallym University Dongtan Sacred Heart Hospital
      • Seoul, 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
      • Suncheon, Korea, Republic of
        • St.Carollo Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital

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
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
12 months and yearly up to 5 years
Stent thrombosis
Time Frame: one month
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.

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

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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