Comparing two approaches for treating blocked coronary arteries

Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions; Systemic Chronic Total Occlusion Revascularization Korea Research-Chronic Total Occlusion (STRIKE-CTO) Study

This study is testing two different methods for treating blocked coronary arteries to see which one works better and is safer for patients with chronic total occlusions.

Quick facts

• Study type: Observational
• Enrollment: 4000 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Asan Medical Center (Academic / other)
• Locations: 32 sites (Anyang and 31 other locations)
• Trial ID: NCT03667196 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of two different approaches, antegrade and retrograde, for performing percutaneous coronary interventions in patients with chronic total occlusions (CTOs) of coronary arteries. It aims to analyze clinical and anatomical differences, success rates, complication patterns, and long-term outcomes associated with each approach. By identifying independent factors that necessitate a retrograde approach, the study seeks to enhance understanding of the best practices for treating CTOs. The findings could inform clinical decision-making and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include patients aged 19 and older with symptomatic chronic total occlusions in coronary arteries.

Not a fit: Patients who are pregnant, have contraindications to contrast medium or antiplatelet drugs, or require surgery that necessitates stopping antiplatelet therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with chronic total occlusions, enhancing their quality of life and reducing complications.

How similar studies have performed: Previous studies have explored similar approaches in treating coronary artery blockages, indicating potential for success, though this specific comparison may provide novel insights.

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.)

Where this trial is running

Anyang and 31 other locations

• Hallym University Sacred Heart Hospital — Anyang, South Korea (Recruiting)
• SoonChunHyang University Hospital Bucheon — Bucheon-si, South Korea (Recruiting)
• Gyeongsang National University Changwon Hospital — Changwon, South Korea (Recruiting)
• Chungbuk National University Hospital — Cheongju-si, South Korea (Recruiting)
• Gangwon National University Hospital — Chuncheon, South Korea (Recruiting)
• Keimyung University Dongsan Medical Center — Daegu, South Korea (Recruiting)
• Yeungnam University Medical Center — Daegu, South Korea (Recruiting)
• Chungnam National University Hospital — Daejeon, South Korea (Recruiting)
• the Catholic University of Korea, Daejeon St. Mary'S Hospital — Daejeon, South Korea (Recruiting)
• The Catholic University of Korea, ST. Vincent's Hospital — Daejeon, South Korea (Recruiting)
• Gangneung Asan Hospital — Gangneung, South Korea (Recruiting)
• Myongji Hospital — Goyang-si, South Korea (Recruiting)
• Hanyang University Medical Center — Guri-si, South Korea (Recruiting)
• Gwangju Veterans Hospital, Korea Veterans Health Service — Gwangju, South Korea (Not_yet_recruiting)
• Chung-Ang University Gwangmyeong Hospital — Gwangmyeong, South Korea (Recruiting)
• Seoul national university Bundang hospital — Gyeonggi-do, South Korea (Recruiting)
• Inha University Hospital — Incheon, South Korea (Recruiting)
• The Catholic University of Korea, Incheon ST. MARY'S Hospital — Incheon, South Korea (Recruiting)
• Busan Veterans Hospital, Korea Veterans Health Service — Pusan, South Korea (Recruiting)
• Dong-A University Hospital — Pusan, South Korea (Recruiting)
• Gosin University Gospel Hospital — Pusan, South Korea (Recruiting)
• Inje University Haeundae Paik Hospital — Pusan, South Korea (Recruiting)
• Inje University Pusan Paik Hospital — Pusan, South Korea (Recruiting)
• Chungnam National University Sejong Hospital — Sejong, South Korea (Recruiting)
• Asan Medical Center — Seoul, South Korea (Recruiting)
• Kangbuk Samsung Hospital — Seoul, South Korea (Recruiting)
• Samsung Medical Center — Seoul, South Korea (Recruiting)
• The Catholic University of Korea, Eunpyeong — Seoul, South Korea (Recruiting)
• The Catholic University of Seoul St. Mary's Hospital — Seoul, South Korea (Recruiting)
• Veterans Hospital Service Medical Center — Seoul, South Korea (Recruiting)
• Ulsan University Hospital — Ulsan, South Korea (Recruiting)
• Pusan National University Yangsan Hospital — Yangsan, South Korea (Recruiting)

Study contacts

• Principal investigator: Seung-Whan Lee, MD — Asan Medical Center
• Study coordinator: Seung-Whan Lee, MD

Conditions Chronic Total Occlusion of Coronary Artery