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Cilotax Stent Implantation Registry

This study is currently recruiting participants.
Verified June 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Information provided by (Responsible Party):
Duk-Woo Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01612819
First received: June 1, 2012
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  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 Cilotax Stent in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-CILOTAX)

Resource links provided by NLM:

U.S. FDA Resources

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: December 2018
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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
6 Locations Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Duk-Woo Park
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

No publications provided

Responsible Party: Duk-Woo 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: June 4, 2012
Health Authority: South Korea: Food and Drug Administration

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 May 23, 2013