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

NCT03667196 | Recruiting

• 1 other identifier: AMCCV 2017-07
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 32

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.

Conditions

Chronic Total Occlusion of Coronary Artery

Outcome Measures

Primary Outcomes (3)

• Death

  Death

  12-month after PCI

• myocardial infarction

  the periprocedural myocardial infarction under the SCAI definition or the non-lethal myocardial infarction during the follow-up observations

  12-month after PCI

• the complex endpoints of target vessel revascularization/reocclusion occurrence

  including chronic total occlusion and angiostenosis

  12-month after PCI

Secondary Outcomes (2)

• Procedure success rate

  every 1-year up-to 5-year

• Myocardial infarction

  every 1-year up-to 5-year

Study Arms (1)

Observational

Procedure: antegrade and retrograde approach

Interventions

antegrade and retrograde approach 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

Observational

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Seung-Whan Lee, M.D., Ph.D.: lead
• Abbott Medical Devices: collaborator
• Biotronik SE & Co. KG: collaborator
• Medtronic: collaborator
• Dio Medical: collaborator

Study Sites (32)

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 Officials

• Seung-Whan Lee, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Whan Lee, MD

CONTACT

8210-7398-9897; seungwlee@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: January 11, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

KR (32)