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Recruiting NCT03667196

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

— Observational Chronic Total Occlusion of Coronary Artery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: antegrade and retrograde approach.
Who it may be relevant to
Registry conditions: Chronic Total Occlusion of Coronary Artery. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Death [Time frame: 12-month after PCI]
  • myocardial infarction [Time frame: 12-month after PCI]
  • the complex endpoints of target vessel revascularization/reocclusion occurrence [Time frame: 12-month after PCI]
Secondary outcome measures (2)
  • Procedure success rate [Time frame: every 1-year up-to 5-year]
  • Myocardial infarction [Time frame: every 1-year up-to 5-year]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 32 centers
  • Hallym University Sacred Heart Hospital — Anyang
  • SoonChunHyang University Hospital Bucheon — Bucheon-si
  • Gyeongsang National University Changwon Hospital — Changwon
  • Chungbuk National University Hospital — Cheongju-si
  • Gangwon National University Hospital — Chuncheon
  • Keimyung University Dongsan Medical Center — Daegu
  • Yeungnam University Medical Center — Daegu
  • Chungnam National University Hospital — Daejeon
  • … and 24 more centers

Identifiers

NCT: NCT03667196 · AMCCV 2017-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗