Clinical trial NCT03667196: Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Total Occlusion of Coronary Artery
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: Biotronik SE & Co. KG
name: Medtronic
name: Dio Medical
First posted: 2018-09-12
Enrollment: 4000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject selection will be determined after screening patients who undergo PCI for CTO lesions and completing the evaluation of all inclusion/exclusion criteria.

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.)

Primary outcomes:
measure: Death
timeFrame: 12-month after PCI
measure: myocardial infarction
timeFrame: 12-month after PCI
measure: the complex endpoints of target vessel revascularization/reocclusion occurrence
timeFrame: 12-month after PCI
Secondary outcomes:
measure: Procedure success rate
timeFrame: every 1-year up-to 5-year
measure: Myocardial infarction
timeFrame: every 1-year up-to 5-year
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: SoonChunHyang University Hospital Bucheon
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: the Catholic University of Korea, Daejeon St. Mary'S Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, ST. Vincent's Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Gwangju
country: Korea, Republic of
facility: Gwangju Veterans Hospital, Korea Veterans Health Service
city: Gwangmyeong
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul national university Bundang hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon ST. MARY'S Hospital
city: Pusan
country: Korea, Republic of
facility: Busan Veterans Hospital, Korea Veterans Health Service
city: Pusan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Pusan
country: Korea, Republic of
facility: Gosin University Gospel Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Sejong
country: Korea, Republic of
facility: Chungnam National University Sejong Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Veterans Hospital Service Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Whan Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: