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NCT03667196
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
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Enrollment: 4000
Sponsor: Seung-Whan Lee, M.D., Ph.D.
Location: Hallym University Sacred Heart Hospital Anyang
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.)
Source: ClinicalTrials.gov (NCT03667196). StuddyBuddy aggregates publicly available trial information.