Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions (STRIKE-CTO)

June 23, 2026 updated by: Seung-Whan Lee, M.D., Ph.D.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Anyang, South Korea
        • Recruiting
        • Hallym University Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Hyun-Sook Kim, MD
      • Bucheon-si, South Korea
        • Recruiting
        • SoonChunHyang University Hospital Bucheon
        • Contact:
        • Principal Investigator:
          • Nae Hee Lee, MD
      • Changwon, South Korea
        • Recruiting
        • Gyeongsang National University Changwon Hospital
        • Contact:
        • Principal Investigator:
          • Jae Seok Bae, MD
      • Cheongju-si, South Korea
        • Recruiting
        • Chungbuk National University Hospital
        • Contact:
        • Principal Investigator:
          • Sang-Min Kim, DM
      • Chuncheon, South Korea
        • Recruiting
        • Gangwon National University Hospital
        • Contact:
        • Principal Investigator:
          • Bong-ki Lee, MD
      • Daegu, South Korea
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
        • Principal Investigator:
          • Hyuck jun yoon, MD
      • Daegu, South Korea
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
        • Principal Investigator:
          • Ung Kim, MD
      • Daejeon, South Korea
        • Recruiting
        • Chungnam National University Hospital
        • Principal Investigator:
          • Jae-Hwan Lee, MD
        • Contact:
      • Daejeon, South Korea
        • Recruiting
        • The Catholic University of Korea, Daejeon St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Kyu-sup Lee
      • Daejeon, South Korea
        • Recruiting
        • The Catholic University of Korea, St. Vincent's Hospital
        • Principal Investigator:
          • Sung-ho Her, MD
        • Contact:
      • Gangneung, South Korea
        • Recruiting
        • Gangneung Asan Hospital
        • Contact:
        • Principal Investigator:
          • Han-bit LeePark, MD
      • Goyang-si, South Korea
        • Recruiting
        • Myongji Hospital
        • Contact:
        • Principal Investigator:
          • Ji-Hyun Lee, MD
      • Guri-si, South Korea
        • Recruiting
        • Hanyang University Medical Center
        • Contact:
        • Principal Investigator:
          • Yong-gu Lee, MD
      • Gwangju, South Korea
        • Recruiting
        • Gwangju Veterans Hospital, Korea Veterans Health Service
        • Contact:
        • Principal Investigator:
          • Won-yu Kang, MD
      • Gwangmyeong, South Korea
        • Recruiting
        • Chung-Ang University Gwangmyeong Hospital
        • Principal Investigator:
          • Sang-Yeub Lee, MD
        • Contact:
      • Gyeonggi-do, South Korea
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Chang-Hwan Yoon, MD
      • Incheon, South Korea
        • Recruiting
        • The Catholic University of Korea, Incheon St. Mary's Hospital
        • Principal Investigator:
          • Ik-joon Choi, MD
        • Contact:
      • Incheon, South Korea
        • Terminated
        • Inha University Hospital
      • Pusan, South Korea
        • Recruiting
        • Inje University Pusan Paik Hospital
        • Contact:
        • Principal Investigator:
          • Tae Hyun Yang, MD
      • Pusan, South Korea
        • Recruiting
        • Dong-A University Hospital
        • Principal Investigator:
          • Yong-rak Cho, MD
        • Contact:
      • Pusan, South Korea
        • Recruiting
        • Busan Veterans Hospital, Korea Veterans Health Service
        • Principal Investigator:
          • Su-Hong Kim, MD
        • Contact:
      • Pusan, South Korea
        • Recruiting
        • Gosin University Gospel Hospital
        • Contact:
        • Principal Investigator:
          • Jeong Ho Heo, MD
      • Pusan, South Korea
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Contact:
        • Principal Investigator:
          • Dong-Kie Kim, MD
      • Sejong, South Korea
        • Recruiting
        • Chungnam National University Sejong Hospital
        • Contact:
        • Principal Investigator:
          • Won-Muk Hwang, MD
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Joo-Yong Hahn, MD
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Seung-Whan Lee, MD
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Veterans Hospital Service Medical Center
        • Principal Investigator:
          • Chang-Hoon Lee, MD
        • Contact:
      • Seoul, South Korea
        • Terminated
        • Kangbuk Samsung Hospital
      • Seoul, South Korea
        • Recruiting
        • The Catholic University of Korea, Eunpyeong
        • Principal Investigator:
          • Suk-Min Seo, MD
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • The Catholic University of Seoul St. Mary's Hospital
        • Principal Investigator:
          • Byung-hee Hwang, MD
        • Contact:
      • Ulsan, South Korea
        • Recruiting
        • Ulsan University Hospital
        • Contact:
        • Principal Investigator:
          • Gyung-Min Park, MD
      • Yangsan, South Korea
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:
        • Principal Investigator:
          • Kook Jin Chun, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Observational
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 12-month after PCI
Death
12-month after PCI
myocardial infarction
Time Frame: 12-month after PCI
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
Time Frame: 12-month after PCI
including chronic total occlusion and angiostenosis
12-month after PCI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure success rate
Time Frame: 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
every 1-year up-to 5-year
Myocardial infarction
Time Frame: every 1-year up-to 5-year
Q-wave VS non-Q-wave, periprocedural myocardial infarction VS follow-up myocardial infarction (spontaneous myocardial infarction
every 1-year up-to 5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seung-Whan Lee, M.D., Ph.D.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic
Abbott Medical Devices
Dio
Teleflex

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seung-Whan Lee, MD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMCCV 2017-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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