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Chronic Total Occlusion of Coronary ArterySTRIKE-CTONCT03667196

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

An observational study of Chronic Total Occlusion of Coronary Artery, run by Seung-Whan Lee, M.D., Ph.D. at 32 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
antegrade and retrograde approach
Type of treatment
Surgery or procedure
How many people
4,000 participants
Where
32 sitesSouth Korea
Study dates
11 Jan 2018to 31 Dec 2032
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.)

Trial locations and contacts

32 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Seung-Whan Lee, MD contact

8210-7398-9897

seungwlee@amc.seoul.kr

32 sites in 1 country

South Korea32 sites, 30 recruiting

  • Hallym University Sacred Heart Hospital

    Anyang

    Hyun-Sook Kim, MD, 8210-6678-1376, hearthsk@hotmail.com

    Hyun-Sook Kim, MD

    Recruiting

  • SoonChunHyang University Hospital Bucheon

    Bucheon-si

    Nae Hee Lee, MD, 8210-9016-9985, naeheelee@naver.com

    Nae Hee Lee, MD

    Recruiting

  • Gyeongsang National University Changwon Hospital

    Changwon

    Jae Seok Bae, MD, 8210-7199-2896, baefach@naver.com

    Jae Seok Bae, MD

    Recruiting

  • Chungbuk National University Hospital

    Cheongju-si

    Sang-Min Kim, DM, 821035518582, sangmin3410@gmail.com

    Sang-Min Kim, DM

    Recruiting

  • Gangwon National University Hospital

    Chuncheon

    Bong-Ki Lee, MD, 8210-6373-9290, mdbklee@kangwon.ac.kr

    Bong-Ki Lee, MD

    Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Hyuck Jun Yoon, MD, 8210-2094-6248, shur@dsmc.or.kr

    Hyuck Jun Yoon, MD

    Recruiting

  • Yeungnam University Medical Center

    Daegu

    Ung Kim, MD, 8210-4504-1507, woongwa@hanmail.net

    Ung Kim, MD

    Recruiting

  • Chungnam National University Hospital

    Daejeon

    Jae-Hwan Lee, MD, 8210-9213-8237, myheart@cnuh.co.kr

    Jae-Hwan Lee, MD

    Recruiting

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

    Daejeon

    Kyu-sup Lee, MD, 8210-9059-0389, ajobi7121@gmail.com

    Kyu-sup Lee

    Recruiting

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

    Daejeon

    Sung-Ho Her, MD, 8210-7731-0052, hhhsungho@hanmail.net

    Sung-Ho Her, MD

    Recruiting

  • Gangneung Asan Hospital

    Gangneung

    Han-bit Park, MD, 8210-8666-6064, phb8012@gmail.com

    Han-bit LeePark, MD

    Recruiting

  • Myongji Hospital

    Goyang-si

    Ji-Hyun Lee, MD, 8210-9120-5427, jihyun.cardio@gmail.com

    Ji-Hyun Lee, MD

    Recruiting

  • Hanyang University Medical Center

    Guri-si

    Yong-gu Lee, MD, 8210-3049-7751, hmedi97@naver.com

    Yong-gu Lee, MD

    Recruiting

  • Gwangju Veterans Hospital, Korea Veterans Health Service

    Gwangju

    Won-yu Kang, MD, +82-62-602-6288, gpkwy@naver.com

    Won-yu Kang, MD

    Recruiting

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong

    Sang-Yeub Lee, MD, 82-10-3551-8582, louisahj@gmail.com

    Sang-Yeub Lee, MD

    Recruiting

  • Seoul national university Bundang hospital

    Gyeonggi-do

    Chang-Hwan Yoon, MD, 8210-2336-9000, changhwanyoon@gmail.com

    Chang-Hwan Yoon, MD

    Recruiting

  • Inha University Hospital

    Incheon

    Terminated

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

    Incheon

    Ik-Joon Choi, MD, mrfasthand@catholic.ac.kr

    Ik-Joon Choi, MD

    Recruiting

  • Busan Veterans Hospital, Korea Veterans Health Service

    Pusan

    Su-Hong Kim, MD, 8210-2571-2149, dhugie@naver.com

    Su-Hong Kim, MD

    Recruiting

  • Dong-A University Hospital

    Pusan

    Yong-Rak Cho, MD, 8210-8553-0723, erygentess@paran.com

    Yong-Rak Cho, MD

    Recruiting

  • Gosin University Gospel Hospital

    Pusan

    Jeong Ho Heo, MD, 8210-2501-2896, duggymdc@gmail.com

    Jeong Ho Heo, MD

    Recruiting

  • Inje University Haeundae Paik Hospital

    Pusan

    Dong-Kie Kim, MD, 8210-4595-9515, imnpymd@gmail.com

    Dong-Kie Kim, MD

    Recruiting

  • Inje University Pusan Paik Hospital

    Pusan

    Tae Hyun Yang, MD, 8210-4590-5067, yangthmd@naver.com

    Tae Hyun Yang, MD

    Recruiting

  • Chungnam National University Sejong Hospital

    Sejong

    Won-Muk Hwang, MD, pascalline@hanmail.net

    Won-Muk Hwang, MD

    Recruiting

  • Asan Medical Center

    Seoul

    Seung-Whan Lee, MD, 8210-7398-9897, seungwlee@amc.seoul.kr

    Seung-Whan Lee, MD

    Recruiting

  • Kangbuk Samsung Hospital

    Seoul

    Terminated

  • Samsung Medical Center

    Seoul

    Joo-Yong Hahn, MD, 8210-9878-3931, jyhahn@skku.edu

    Joo-Yong Hahn, MD

    Recruiting

  • The Catholic University of Korea, Eunpyeong

    Seoul

    Suk-Min Seo, MD, 8210-7358-5252, ssm530@catholic.ac.kr

    Suk-Min Seo, MD

    Recruiting

  • The Catholic University of Seoul St. Mary's Hospital

    Seoul

    Byung-Hee Hwang, MD, 8210-5358-2597, hbhmac@naver.com

    Byung-Hee Hwang, MD

    Recruiting

  • Veterans Hospital Service Medical Center

    Seoul

    Chang-Hoon Lee, MD, 8210-5551-7867, changhoon.lee121@gmail.com

    Chang-Hoon Lee, MD

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Gyung-Min Park, MD, 8210-9995-8684, min8684@hanmail.net

    Gyung-Min Park, MD

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan

    Kook Jin Chun, MD, 8210-6342-2299, ptca82@gmail.com

    Kook Jin Chun, MD

    Recruiting

Other trials in South Korea

About this study

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

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.

Being tested
antegrade and retrograde approach

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • antegrade and retrograde approachProcedure or surgery

    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

Study groups in NCT03667196
Study groupRoleWhat they receive
ObservationalNot described
Receives: Procedure: antegrade and retrograde approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death

    Death

    Measured: 12-month after PCI

  2. myocardial infarction

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

    Measured: 12-month after PCI

  3. the complex endpoints of target vessel revascularization/reocclusion occurrence

    including chronic total occlusion and angiostenosis

    Measured: 12-month after PCI

Secondary outcomes (2)

  1. Procedure success rate

    A procedure success defined as the case where a final vessel diameter stenosis < 30% is achieved after the stent insertion

    Measured: every 1-year up-to 5-year

  2. Myocardial infarction

    Q-wave VS non-Q-wave, periprocedural myocardial infarction VS follow-up myocardial infarction (spontaneous myocardial infarction

    Measured: every 1-year up-to 5-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start11 Jan 2018
  3. Primary completion31 Dec 2032 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03667196
Sponsor's protocol ID
AMCCV 2017-07
Acronym
STRIKE-CTO
Status last verified
Jun 2026
First submitted
10 Sep 2018
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Total Occlusion of Coronary Artery, run by Seung-Whan Lee, M.D., Ph.D. at 32 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seung-Whan Lee, MD (8210-7398-9897, seungwlee@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death (time frame: 12-month after PCI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03667196.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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