NCT03667196 Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions
| NCT ID | NCT03667196 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seung-Whan Lee, M.D., Ph.D. |
| Condition | Chronic Total Occlusion of Coronary Artery |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2018-01-11 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,000 participants in total. It began in 2018-01-11 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.)
Contact & Investigator
Seung-Whan Lee, MD
PRINCIPAL INVESTIGATOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT03667196 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Chronic Total Occlusion of Coronary Artery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03667196 currently recruiting?
Yes, NCT03667196 is actively recruiting participants. Contact the research team at seungwlee@amc.seoul.kr for enrollment information.
Where is the NCT03667196 trial being conducted?
This trial is being conducted at Anyang, South Korea, Bucheon-si, South Korea, Changwon, South Korea, Cheongju-si, South Korea and 11 additional locations.
Who is sponsoring the NCT03667196 clinical trial?
NCT03667196 is sponsored by Seung-Whan Lee, M.D., Ph.D.. The principal investigator is Seung-Whan Lee, MD at Asan Medical Center. The trial plans to enroll 4,000 participants.