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NCT Number: NCT03667196

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallym University Sacred Heart Hospital, Anyang, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

Primary outcomes

  1. Death

    Time frame: 12-month after PCI

    Death

  2. 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

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

    Time frame: 12-month after PCI

    including chronic total occlusion and angiostenosis

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Seung-Whan Lee, MD

CONTACT

[email protected]

8210-7398-9897

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Abbott Medical Devices
  • Dio
  • Medtronic
  • Teleflex

Registry information

Official study 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

Acronym: STRIKE-CTO

Important dates

Study start
2018
Primary completion
2032
Study completion
2032
First posted
Sep 12, 2018
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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