Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions
- Conditions
- Chronic Total Occlusion of Coronary Artery
- Interventions
- Procedure: antegrade and retrograde approach
- Registration Number
- NCT03667196
- Lead Sponsor
- Seung-Whan Lee, M.D., Ph.D.
- Brief Summary
Objective of this study is to 1) analyze the clinical, anatomical and periprocedural differences of patients who underwent a procedure related to coronary CTO through the antergrade approach and retrograde approach; 2) analyze the success rate of the procedures and the incidence and patterns of complications; 3) compare and analyze long-term performances after the successful procedure; and 4) identify the independent factors that require a retrograde approach and the prognostic factor regarding long-term performances after use of each approach.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4000
- Patients aged>=19
- Patients who have a CTO lesion in at least one or more epicardial coronary artery 2.5 mm in blood vessel diameter
- Patients who have symptoms of angina or objectively proven myocardial ischemia (asymptomatic myocardial ischemia, stable or unstable angina, non - -ST-segment elevation myocardial infarction)
- Patients who voluntarily agreed to the protocol and the clinical follow-up plan (or let their representative do this), and signed the informed consent form approved by the IRB of each study institute
- Patients who are pregnant or lactating or have childbearing potential Patients in whom contrast medium and heparin are contraindicated or who are hypersensitive to them
- Patients in whom aspirin, clopidogrel, ticagrelor and prasugrel, cilostazol are contraindicated
- Patients scheduled to undergo a surgery, etc. that requires discontinuance of an antiplatelet drug within 12 months after participation in the study
- Acute ST elevation myocardial infarction at the time of hospitalization
- Terminally ill patients with their life expectancy < one year
- Patients who have serious diseases other than cardiac diseases that may affect limitation of residual life time or observation of the protocol (e.g. oxygen-independent chronic obstructive pulmonary disease, persisting hepatitis or serious hepatic insufficiency, severe renal disease, etc. Be left up to the discretion of the investigator.)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational antegrade and retrograde approach -
- Primary Outcome Measures
Name Time Method Death 12-month after PCI Death
myocardial infarction 12-month after PCI the periprocedural myocardial infarction under the SCAI definition or the non-lethal myocardial infarction during the follow-up observations
the complex endpoints of target vessel revascularization/reocclusion occurrence 12-month after PCI including chronic total occlusion and angiostenosis
- Secondary Outcome Measures
Name Time Method Myocardial infarction every 1-year up-to 5-year Q-wave VS non-Q-wave, periprocedural myocardial infarction VS follow-up myocardial infarction (spontaneous myocardial infarction
Procedure success rate every 1-year up-to 5-year A procedure success defined as the case where a final vessel diameter stenosis \< 30% is achieved after the stent insertion
Trial Locations
- Locations (32)
Gwangju Veterans Hospital, Korea Veterans Health Service
🇰🇷Gwangju, Korea, Republic of
Chung-Ang University Gwangmyeong Hospital
🇰🇷Gwangmyeong, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
SoonChunHyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Gyeongsang National University Changwon Hospital
🇰🇷Changwon, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Gangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
the Catholic University of Korea, Daejeon St. Mary'S Hospital
🇰🇷Daejeon, Korea, Republic of
The Catholic University of Korea, ST. Vincent's Hospital
🇰🇷Daejeon, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Myongji Hospital
🇰🇷Goyang-si, Korea, Republic of
Hanyang University Medical Center
🇰🇷Guri-si, Korea, Republic of
Seoul national university Bundang hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
The Catholic University of Korea, Incheon ST. MARY'S Hospital
🇰🇷Incheon, Korea, Republic of
Busan Veterans Hospital, Korea Veterans Health Service
🇰🇷Pusan, Korea, Republic of
Dong-A University Hospital
🇰🇷Pusan, Korea, Republic of
Gosin University Gospel Hospital
🇰🇷Pusan, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Pusan, Korea, Republic of
Inje University Pusan Paik Hospital
🇰🇷Pusan, Korea, Republic of
Chungnam National University Sejong Hospital
🇰🇷Sejong, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Eunpyeong
🇰🇷Seoul, Korea, Republic of
The Catholic University of Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Veterans Hospital Service Medical Center
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of