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DXR Stent(Previous Cilotax) Implantation Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
Cardiotec Corporation
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01612819
First received: June 1, 2012
Last updated: December 12, 2016
Last verified: December 2016
  Purpose
Registry of cilotax stent(Dual drug eluting stent) implantation for CAD patients

Condition
Coronary Artery Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of DXR(Previous Cilotax) Stent in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-CILOTAX)

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) [ Time Frame: at 12 months post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death (all cause and cardiac) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Death (all cause and cardiac) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Death (all cause and cardiac) [ Time Frame: 12 months and yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: 12 months and yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 12 months and yearly upto 5 years ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 12 months and yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization [ Time Frame: 12 months and yearly up to 5 years ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Target Vessel Revascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target-lesion revascularization [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Target-lesion revascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target-lesion revascularization [ Time Frame: 12 months and yearly up to 5 years ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: 12 months and yearly up to 5 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Procedural success [ Time Frame: at day 1 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1000
Study Start Date: April 2012
Estimated Study Completion Date: February 2023
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with coronary artery disease requiring drug eluting stents
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612819

Contacts
Contact: Seung-Jung Park, MD, PhD 82-2-3010-4812 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD 82-2-3010-3995 dwpark@amc.seoul.kr

Locations
Korea, Republic of
Soonchunhyang University Hospital, Buchen Recruiting
Bucheon, Korea, Republic of
Contact: Nae-hee Lee, MD       naeheelee@naver.com   
Principal Investigator: Nae-hee Lee, MD         
Dankook University Hospital Recruiting
Cheonan, Korea, Republic of
Contact: Byung-eun Park, MD       ad7525@dankook.ac.kr   
Principal Investigator: Byung-eun Park, MD         
Kangwon National University Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Bong-ki Lee, MD       mdbklee@kangwon.ac.kr   
Principal Investigator: Bong-ki Lee, MD         
Daegu Catholic University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Kee-sik Kim, MD       kks7379@cu.ac.kr   
Principal Investigator: Kee-sik Kim, MD         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Seung-ho Hur, MD       shur@dsmc.or.kr   
Principal Investigator: Seung-ho Hur, MD         
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Jong-seon Park, MD       pjs@med.yu.ac.kr   
Principal Investigator: Jong-sun Park, MD         
Daejeon St. Mary's Hospital, The Catholic University of Korea Recruiting
Daejeon, Korea, Republic of
Contact: Sung-ho Her, MD       hhhsungho@hanmail.net   
Principal Investigator: Sung-ho Her, MD         
GangNeung Asan Hospital Recruiting
Gangneung, Korea, Republic of
Contact: Changkun Lee, MD       ckdreams@gmail.com   
Principal Investigator: Changkun Lee, MD         
Gwangju Veterans Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Won-yu Kang, MD       gpkwy@naver.com   
Principal Investigator: Won-yu Kang, MD         
Kwangju Christian Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Seung-uk Lee, MD       cardiosu@hanmail.net   
Principal Investigator: Seung-uk Lee, MD         
Dongguk university gyeongju hospital Recruiting
Gyeongju, Korea, Republic of
Contact: Deuk-young Nah, MD       ptca@dongguk.ac.kr   
Principal Investigator: Deuk-young Nah, MD         
Hallym University Dongtan Sacred Heart Hospital Recruiting
Hwasong, Korea, Republic of
Contact: Seok-won Choi, MD       swchoi97@gmail.com   
Principal Investigator: Seok-won Choi, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-jung Park, MD       sjpark@amc.seoul.kr   
Principal Investigator: Seung-jung Park, MD         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyuk-moon Kwon, MD       kwonhm@yuhs.ac   
Principal Investigator: Hyuk-moon Kwon, MD         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung-un Rha, MD       swrha617@yahoo.co.kr   
Principal Investigator: Seung-un Rha, MD         
Kyung-Hee University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Soo-joong Kim, MD       soojoong@dreamwiz.com   
Principal Investigator: Soo-joong Kim, MD         
Seoul St. Mary's Hospital, The Catholic University of Korea Recruiting
Seoul, Korea, Republic of
Contact: Ki-bae Seung, MD       kbseung@catholic.ac.kr   
Principal Investigator: Ki-bae Seung, MD         
ST.Carollo Hospital Recruiting
Suncheon, Korea, Republic of
Contact: Jang-hyun Cho, MD       goodnew8@naver.com   
Principal Investigator: Jang-hyun Cho, MD         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Eun-seok Shin, MD       sesim98@yahoo.co.kr   
Principal Investigator: Eun-seok Shin, MD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Cardiotec Corporation
Investigators
Principal Investigator: Ki Bae Seung, MD, PhD Seoul St. Mary's Hospital, Catholic University of Korea
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
  More Information

Responsible Party: Seung-Jung Park, MD, PhD, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01612819     History of Changes
Other Study ID Numbers: CVRF2012-01 
Study First Received: June 1, 2012
Last Updated: December 12, 2016
Health Authority: Korea: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on January 17, 2017