Coronary Artery DiseasesNCT01612819
DXR Stent(Previous Cilotax) Implantation Registry
An observational study of Coronary Artery Diseases, run by Seung-Jung Park at 18 sites in South Korea.
Trial summary
Registry of cilotax stent(Dual drug eluting stent) implantation for CAD patients Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Diseases
- How many people
- 451 participants
- Where
- 18 sitesSouth Korea
- Study dates
- Apr 2012to 30 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with coronary artery disease requiring drug eluting stents
Who may be able to join
- 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
Who cannot join
- Patients with a mixture of other DESs
- Terminal illness with life expectancy <1 year
- Patients presented with cardiogenic shock
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
Soonchunhyang University Hospital, Buchen
Bucheon-si
Dankook University Hospital
Cheonan
Kangwon National University Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Yeungnam University Medical Center
Daegu
Daejeon St. Mary's Hospital, The Catholic University of Korea
Daejeon
GangNeung Asan Hospital
Gangneung
Gwangju Veterans Hospital
Gwangju
Kwangju Christian Hospital
Gwangju
Dongguk university gyeongju hospital
Gyeongju
Hallym University Dongtan Sacred Heart Hospital
Hwasŏng
Asan Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Korea University Guro Hospital
Seoul
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul
ST.Carollo Hospital
Suncheon
Ulsan University Hospital
Ulsan
About this study
Official title: 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
- Conditions
- Coronary Artery Diseases
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
Measured: at 12 months post procedure
Secondary outcomes (22)
Death (all cause and cardiac)
Measured: one month
Death (all cause and cardiac)
Measured: 6 months
Death (all cause and cardiac)
Measured: 12 months and yearly up to 5 years
Myocardial Infarction
Measured: 12 months and yearly up to 5 years
Myocardial Infarction
Measured: one month
Myocardial Infarction
Measured: 6 months
Composite of death or MI
Measured: 6 months
Composite of death or MI
Measured: one month
Composite of death or MI
Measured: 12 months and yearly upto 5 years
Composite of cardiac death or MI
Measured: one month
Composite of cardiac death or MI
Measured: 6 months
Composite of cardiac death or MI
Measured: 12 months and yearly up to 5 years
Target Vessel Revascularization
Measured: 12 months and yearly up to 5 years
Target Vessel Revascularization
Measured: one month
Target Vessel Revascularization
Measured: 6 months
Target-lesion revascularization
Measured: one month
Target-lesion revascularization
Measured: 6 months
Target-lesion revascularization
Measured: 12 months and yearly up to 5 years
Stent thrombosis
Measured: 12 months and yearly up to 5 years
Stent thrombosis
Measured: one month
Stent thrombosis
Measured: 6 months
Procedural success
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.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startApr 2012
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Why it stopped: No more enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Cardiotec Corporation
- Responsible party
- Sponsor-investigator, Seung-Jung Park, CardioVascular Research Foundation, Korea
- Investigators
- Ki Bae Seung, MD, PhD, Principal investigator, Seoul St. Mary's Hospital, Catholic University of KoreaSeung-Jung Park, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612819
- Sponsor's protocol ID
- CVRF2012-01
- Status last verified
- Mar 2017
- First submitted
- 1 Jun 2012
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This is not a publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of DXR(Previous Cilotax) Stent in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-CILOTAX)
- ClinicalTrials.gov ID
- NCT01612819
- Acronym / sponsor ID
- CVRF2012-01
- Conditions
- Coronary Artery Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No more enrollment
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Cardiotec Corporation
- Study start
- Apr 2012 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 6 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Registry of cilotax stent(Dual drug eluting stent) implantation for CAD patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with coronary artery disease requiring drug eluting stents
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with a mixture of other DESs
- Terminal illness with life expectancy <1 year
- Patients presented with cardiogenic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
Time frame: at 12 months post procedure
22 secondary outcomes
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
Results and safety
The study was stopped early (reason given: No more enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Diseases, run by Seung-Jung Park at 18 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No more enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) (time frame: at 12 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.