Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions

Recruiting

• Conditions: Chronic Total Occlusion of Coronary Artery

• 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

Study Timeline

• Study Start: 2018-01-11
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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

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