Concurrent OCT and FFR-guided PCI in CAD (OPTICARE-CAD)

Korea University

Status: Enrolling

Conditions: Coronary Artery Disease; Atheroscleroses, Coronary; Image

Treatments: Diagnostic Test: optical coherence tomography and fractional flow reserve; Diagnostic Test: Coronary angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT06182683

OPTICARE-CAD_v1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Angiography-guided PCI group

Active Comparator group

Description:

This group of patients are intended to undergo PCI with conventional angiography-guidance. Procedural optimization determined by angiographic assessment.

Treatment:

Diagnostic Test: Coronary angiography

Concurrent OCT/FFR-guided PCI group

Experimental group

Description:

This group of patients are intended to undergo PCI with concurrent OCT/FFR-guidance. Procedural optimization determined by OCT and FFR assessment.

Treatment:

Diagnostic Test: optical coherence tomography and fractional flow reserve

Diagnostic Test: Coronary angiography