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Concurrent OCT and FFR-guided PCI in CAD

Concurrent OCT and FFR-guided PCI in CAD

Recruiting
19 years and older
All
Phase N/A

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Overview

The present study is a prospective randomized clinical trial aimed to compare the therapeutic strategy of angiography-guided versus concurrent OCT/FFR-guided intervention in patients with coronary artery disease.

Description

Most previous clinical trials have assessed various interventional strategies guided by intravascular imaging (intravascular imaging-guided PCI), fractional flow reserve (FFR-guided PCI), or conventional angiography (angiography-guided PCI) to compare differences in treatment outcomes. Until now, it remains unclear whether optimizing procedures based on both intravascular imaging and fractional flow reserve indices would lead to improved treatment outcomes compared to PCI guided solely by conventional angiography. Moreover, there are no studies comparing a treatment strategy that combines optical coherence tomography (OCT) and FFR to angiography-guided procedures. Hence, this study aims to compare the clinical effectiveness and therapeutic impact of concurrent guidance using FFR and OCT in patients undergoing coronary artery stent implantation, as compared to procedures guided solely by conventional angiography.

Eligibility

Inclusion Criteria:

  1. Age greater than 19 years old
  2. Patients undergoing coronary stent implantation for stable angina or acute coronary syndrome
  3. Patients provided on informed consent

Exclusion Criteria:

  1. Individuals with a history of increased bleeding tendencies or hematologic disorders
  2. Presented with refractory cardiogenic shock
  3. Individuals with a history of stent thrombosis
  4. Expected life expectancy of less than 1 year
  5. Left ventricular ejection fraction (LVEF) ≥ 20%
  6. Women who are breastfeeding, pregnant, or planning to become pregnant
  7. Deemed unsuitable for participation by the investigator
  8. Patients unwilling to participate in the clinical trial

Study details
    Coronary Artery Disease
    Image
    Atheroscleroses
    Coronary

NCT06182683

Korea University Guro Hospital

25 January 2024

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