Clinical trial NCT01612819: DXR Stent(Previous Cilotax) Implantation Registry
Official title: Evaluation of Effectiveness and Safety of DXR(Previous Cilotax) Stent in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-CILOTAX)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Diseases
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: Cardiotec Corporation
First posted: 2012-06-06
Enrollment: 451
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with coronary artery disease requiring drug eluting stents

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


Eligibility 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

Primary outcomes:
measure: composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
timeFrame: at 12 months post procedure
Secondary outcomes:
measure: Death (all cause and cardiac)
timeFrame: one month
measure: Death (all cause and cardiac)
timeFrame: 6 months
measure: Death (all cause and cardiac)
timeFrame: 12 months and yearly up to 5 years
measure: Myocardial Infarction
timeFrame: 12 months and yearly up to 5 years
measure: Myocardial Infarction
timeFrame: one month
measure: Myocardial Infarction
timeFrame: 6 months
measure: Composite of death or MI
timeFrame: 6 months
measure: Composite of death or MI
timeFrame: one month
measure: Composite of death or MI
timeFrame: 12 months and yearly upto 5 years
measure: Composite of cardiac death or MI
timeFrame: one month
measure: Composite of cardiac death or MI
timeFrame: 6 months
measure: Composite of cardiac death or MI
timeFrame: 12 months and yearly up to 5 years
measure: Target Vessel Revascularization
timeFrame: 12 months and yearly up to 5 years
measure: Target Vessel Revascularization
timeFrame: one month
measure: Target Vessel Revascularization
timeFrame: 6 months
measure: Target-lesion revascularization
timeFrame: one month
measure: Target-lesion revascularization
timeFrame: 6 months
measure: Target-lesion revascularization
timeFrame: 12 months and yearly up to 5 years
measure: Stent thrombosis
timeFrame: 12 months and yearly up to 5 years
measure: Stent thrombosis
timeFrame: one month
measure: Stent thrombosis
timeFrame: 6 months
measure: Procedural success
timeFrame: at day 1
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hospital, Buchen
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Daejeon St. Mary's Hospital, The Catholic University of Korea
city: Gangneung
country: Korea, Republic of
facility: GangNeung Asan Hospital
city: Gwangju
country: Korea, Republic of
facility: Gwangju Veterans Hospital
city: Gwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Gyeongju
country: Korea, Republic of
facility: Dongguk university gyeongju hospital
city: Hwasong
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
city: Suncheon
country: Korea, Republic of
facility: ST.Carollo Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital, Catholic University of Korea
name: Ki Bae Seung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: