Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions (STRIKE-CTO)

Seung-Whan Lee, M.D., Ph.D.

Status: Enrolling

Conditions: Chronic Total Occlusion of Coronary Artery

Treatments: Procedure: antegrade and retrograde approach

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03667196

AMCCV 2017-07

Details and patient eligibility

About

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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

4,000 participants in 1 patient group

Observational

Treatment:

Procedure: antegrade and retrograde approach