DXR Stent(Previous Cilotax) Implantation Registry

Coronary Artery Diseases Clinical Trial

Official title:

Evaluation of Effectiveness and Safety of DXR(Previous Cilotax) Stent in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-CILOTAX)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01612819
• Other study ID #: CVRF2012-01
• Status: Terminated
• Phase: N/A
• First received: June 1, 2012
• Last updated: March 30, 2017
• Start date: April 2012
• Est. completion date: March 30, 2017

Study information

• Verified date: March 2017
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 451
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Diseases
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
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

Sponsors (3)

Lead Sponsor	Collaborator
Seung-Jung Park	Cardiotec Corporation, CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)		at 12 months post procedure
Secondary	Death (all cause and cardiac)		one month
Secondary	Death (all cause and cardiac)		6 months
Secondary	Death (all cause and cardiac)		12 months and yearly up to 5 years
Secondary	Myocardial Infarction		12 months and yearly up to 5 years
Secondary	Myocardial Infarction		one month
Secondary	Myocardial Infarction		6 months
Secondary	Composite of death or MI		6 months
Secondary	Composite of death or MI		one month
Secondary	Composite of death or MI		12 months and yearly upto 5 years
Secondary	Composite of cardiac death or MI		one month
Secondary	Composite of cardiac death or MI		6 months
Secondary	Composite of cardiac death or MI		12 months and yearly up to 5 years
Secondary	Target Vessel Revascularization		12 months and yearly up to 5 years
Secondary	Target Vessel Revascularization		one month
Secondary	Target Vessel Revascularization		6 months
Secondary	Target-lesion revascularization		one month
Secondary	Target-lesion revascularization		6 months
Secondary	Target-lesion revascularization		12 months and yearly up to 5 years
Secondary	Stent thrombosis		12 months and yearly up to 5 years
Secondary	Stent thrombosis		one month
Secondary	Stent thrombosis		6 months
Secondary	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.	at day 1