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

NCT ID: NCT03667196

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-11

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Chronic Total Occlusion of Coronary Artery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

antegrade and retrograde approach

Intervention Type PROCEDURE

This study intends to identify and compare the clinical, anatomical and periprocedural factors of the patients who used only the antergrade approach and the patients who needed the retrograde approach among the patients with coronary CTO

Interventions

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antegrade and retrograde approach

This study intends to identify and compare the clinical, anatomical and periprocedural factors of the patients who used only the antergrade approach and the patients who needed the retrograde approach among the patients with coronary CTO

Intervention Type PROCEDURE

Eligibility Criteria

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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.)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role collaborator

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

Dio Medical

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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

M.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Seung-Whan Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status RECRUITING

SoonChunHyang University Hospital Bucheon

Bucheon-si, , South Korea

Site Status RECRUITING

Gyeongsang National University Changwon Hospital

Changwon, , South Korea

Site Status RECRUITING

Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status RECRUITING

Gangwon National University Hospital

Chuncheon, , South Korea

Site Status RECRUITING

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status RECRUITING

Yeungnam University Medical Center

Daegu, , South Korea

Site Status RECRUITING

Chungnam National University Hospital

Daejeon, , South Korea

Site Status RECRUITING

the Catholic University of Korea, Daejeon St. Mary'S Hospital

Daejeon, , South Korea

Site Status RECRUITING

The Catholic University of Korea, ST. Vincent's Hospital

Daejeon, , South Korea

Site Status RECRUITING

Gangneung Asan Hospital

Gangneung, , South Korea

Site Status RECRUITING

Myongji Hospital

Goyang-si, , South Korea

Site Status RECRUITING

Hanyang University Medical Center

Guri-si, , South Korea

Site Status RECRUITING

Gwangju Veterans Hospital, Korea Veterans Health Service

Gwangju, , South Korea

Site Status NOT_YET_RECRUITING

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, , South Korea

Site Status RECRUITING

Seoul national university Bundang hospital

Gyeonggi-do, , South Korea

Site Status RECRUITING

Inha University Hospital

Incheon, , South Korea

Site Status RECRUITING

The Catholic University of Korea, Incheon ST. MARY'S Hospital

Incheon, , South Korea

Site Status RECRUITING

Busan Veterans Hospital, Korea Veterans Health Service

Pusan, , South Korea

Site Status RECRUITING

Dong-A University Hospital

Pusan, , South Korea

Site Status RECRUITING

Gosin University Gospel Hospital

Pusan, , South Korea

Site Status RECRUITING

Inje University Haeundae Paik Hospital

Pusan, , South Korea

Site Status RECRUITING

Inje University Pusan Paik Hospital

Pusan, , South Korea

Site Status RECRUITING

Chungnam National University Sejong Hospital

Sejong, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

The Catholic University of Korea, Eunpyeong

Seoul, , South Korea

Site Status RECRUITING

The Catholic University of Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Veterans Hospital Service Medical Center

Seoul, , South Korea

Site Status RECRUITING

Ulsan University Hospital

Ulsan, , South Korea

Site Status RECRUITING

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seung-Whan Lee, MD

Role: CONTACT

Phone: 8210-7398-9897

Email: [email protected]

Facility Contacts

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Hyun-Sook Kim, MD

Role: primary

Nae Hee Lee, MD

Role: primary

Jae Seok Bae, MD

Role: primary

Sang-Min Kim, DM

Role: primary

Bong-Ki Lee, MD

Role: primary

Hyuck Jun Yoon, MD

Role: primary

Ung Kim, MD

Role: primary

Jae-Hyeong Park, MD

Role: primary

Kyu-sup Lee, MD

Role: primary

Sung-Ho Her, MD

Role: primary

Han-bit Park, MD

Role: primary

Ji-Hyun Lee, MD

Role: primary

Yong-gu Lee, MD

Role: primary

Won-yu Kang, MD

Role: primary

Sang-Yeub Lee, MD

Role: primary

Chang-Hwan Yoon, MD

Role: primary

Seong-Ill Woo, MD

Role: primary

Seong-Ill Woo, MD

Role: backup

Doo Soo Jeon, MD

Role: primary

Su-Hong Kim, MD

Role: primary

Yong-Rak Cho, MD

Role: primary

Jeong Ho Heo, MD

Role: primary

Dong-Kie Kim, MD

Role: primary

Tae Hyun Yang, MD

Role: primary

Jae-Hwan LeeJae-Hwan, MD

Role: primary

Seung-Whan Lee, MD

Role: primary

Jong-Young Lee, MD

Role: primary

Joo-Yong Hahn, MD

Role: primary

Suk-Min Seo, MD

Role: primary

Byung-Hee Hwang, MD

Role: primary

Chang-Hoon Lee, MD

Role: primary

Gyung-Min Park, MD

Role: primary

Kook Jin Chun, MD

Role: primary

Other Identifiers

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AMCCV 2017-07

Identifier Type: -

Identifier Source: org_study_id