DXR Stent(Previous Cilotax) Implantation Registry

NCT01612819 | Terminated

• 1 other identifier: CVRF2012-01
• Study Type: observational
• Target: 451
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Coronary Artery Diseases

Outcome Measures

Primary Outcomes (1)

• composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)

  at 12 months post procedure

Secondary Outcomes (22)

• Death (all cause and cardiac)

  one month

• Death (all cause and cardiac)

  6 months

• Death (all cause and cardiac)

  12 months and yearly up to 5 years

• Myocardial Infarction

  12 months and yearly up to 5 years

• Myocardial Infarction

  one month

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with coronary artery disease requiring drug eluting stents

You may qualify if:

• 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

You may not qualify if:

• Patients with a mixture of other DESs
• Terminal illness with life expectancy \<1 year
• Patients presented with cardiogenic shock

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator
• Cardiotec Corporation: collaborator

Study Sites (18)

Soonchunhyang University Hospital, Buchen

Bucheon-si, South Korea

Location

Dankook University Hospital

Cheonan, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Daejeon St. Mary's Hospital, The Catholic University of Korea

Daejeon, South Korea

Location

GangNeung Asan Hospital

Gangneung, South Korea

Location

Gwangju Veterans Hospital

Gwangju, South Korea

Location

Kwangju Christian Hospital

Gwangju, South Korea

Location

Dongguk university gyeongju hospital

Gyeongju, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Hwasŏng, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

Location

ST.Carollo Hospital

Suncheon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ki Bae Seung, MD, PhD

  Seoul St. Mary's Hospital, Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Seung-Jung Park, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 6, 2012
• Study Start: April 1, 2012
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (18)