Ireland
--:--IST
Recruiting Not applicable

Anatomic Versus Physiologic Guidance for Complete Revascularization With DES Eluting in Patients With CAD

NCT05529459 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2023-03-13
Last updated
2025-01-10

Condition(s) studied

Coronary Disease

Investigational drug(s) / intervention(s)

Percutaneous Coronary Intervention

Percutaneous Coronary Intervention: Percutaneous Coronary Intervention

Study summary

This study is to compare clinical outcomes between quantitative coronary angiography-guided anatomic complete revascularization and fractional flow reserve-guided physiologic complete revascularization in patients with significant coronary artery disease undergoing percutaneous coronary intervention with drug eluting stent

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Men or women between the ages of 19and older * Typical chest pain or objective evidence of myocardial ischemia suitable for PCI Significant lesions with a diameter stenosis of 50-90% in major epicardial coronary arteries ≥ 2.25 mm in diameter by visual estimation. * The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: * Coronary lesions resulting in the expected inability to perform FFR (ex, severe tortuosity or extreme angulation of the vessels) * Chronic total occlusion * Failed PCI of severe stenotic (diameter stenosis \> 90%) or ACS culprit lesions * Previous PCI within 6 months before the index procedure * Previous coronary artery bypass graft surgery * Cardiogenic shock or hemodynamic instability * Left ventricular dysfunction (ejection fraction \< 35%) * Life expectancy \< 1 years for any non-cardiac or cardiac causes * Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure * A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer * Patient's pregnant or breast-feeding or child-bearing potential. * A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or ticagrelor) * Hypersensitivity or contraindication to DES material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated * Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study * Unwillingness or inability to comply with the procedures described in this protocol

Primary outcome measure(s)

  • Number of Participants with death — 12month
    Major adverse cardiac events are defined as all-cause death
  • Number of Participants with MI — 12month
    Non-fatal myocardial infarction includes both spontaneous MI and periprocedural MI.
  • Number of Participants with unplanned repeat revascularization — 12month
    Unplanned repeat revascularization is defined as revascularization of any diseased coronary arteries ≥ 2.0 mm in diameter by QCA due to recurred angina with at least one of the following: (1) positive non-invasive test, (2) positive invasive physiologic test, or (3) presence of diameter stenosis ≥50% by QCA.

Trial sites (17)

FacilityCityRegionStatus
Hallym University Sacred Heart Hospital Anyang South Korea Not Yet Recruiting
Bucheon Sejong Hospital Bucheon-si South Korea Not Yet Recruiting
Inje University Busan Paik Hospital Busan South Korea Recruiting
Gyeongsang National University Changwon Hospital Changwon South Korea Recruiting
Chungbuk National University Hospital Cheongju-si South Korea Recruiting
Daegu Veterans Hospital Daegu South Korea Recruiting
Keimyung University Dongsan Medical Center Daegu South Korea Recruiting
Gangneung Asan Hospital Gangneung South Korea Recruiting
Wonkwang University Hospital Iksan South Korea Recruiting
Kwangju Christian Hospital Kwangju South Korea Recruiting
Inje University Pusan Paik Hospital Pusan South Korea Recruiting
Bundang CHA Hospital Seongnam South Korea Not Yet Recruiting
Asan Medical Center Seoul South Korea Recruiting
Korea University Anam Hospital Seoul South Korea Recruiting
Veterans Hospital Service Medical Center Seoul South Korea Recruiting
The Catholic University of Korea, ST. Vincent's Hospital Suwon South Korea Not Yet Recruiting
Pusan National University Yangsan Hospital Yangsan South Korea Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05529459 on ClinicalTrials.gov ↗ ← All trials in South Korea