DXR Stent(Previous Cilotax) Implantation Registry

Terminated

• Conditions: Coronary Artery Diseases

• Registration Number: NCT01612819
• Lead Sponsor: Seung-Jung Park

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-06
• Status Verified: 2017-03
• Primary Completion: 2017-03-30
• Study Completion: 2017-03-30
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 451

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)	at 12 months post procedure

Secondary Outcome Measures

Name	Time	Method
Death (all cause and cardiac)	12 months and yearly up to 5 years
Myocardial Infarction	6 months
Procedural success	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.
Stent thrombosis	6 months
Composite of death or MI	12 months and yearly upto 5 years
Composite of cardiac death or MI	12 months and yearly up to 5 years
Target Vessel Revascularization	6 months
Target-lesion revascularization	12 months and yearly up to 5 years

Trial Locations

Locations (18)

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

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