Concurrent OCT and FFR-guided PCI in CAD

Not Applicable

Recruiting

• Conditions: Image; Coronary Artery Disease; Atheroscleroses, Coronary
• Interventions: Diagnostic Test: optical coherence tomography and fractional flow reserve; Diagnostic Test: Coronary angiography

• Registration Number: NCT06182683
• Lead Sponsor: Korea University Guro Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-28
• Study Start: 2023-11-30
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-25
• Last Update Submitted: 2023-12-25
• Study First Posted: 2023-12-27
• Last Update Posted: 2023-12-27
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concurrent OCT/FFR-guided PCI group	Coronary angiography	This group of patients are intended to undergo PCI with concurrent OCT/FFR-guidance. Procedural optimization determined by OCT and FFR assessment.
Angiography-guided PCI group	Coronary angiography	This group of patients are intended to undergo PCI with conventional angiography-guidance. Procedural optimization determined by angiographic assessment.
Concurrent OCT/FFR-guided PCI group	optical coherence tomography and fractional flow reserve	This group of patients are intended to undergo PCI with concurrent OCT/FFR-guidance. Procedural optimization determined by OCT and FFR assessment.

Primary Outcome Measures

Name	Time	Method
Rate of target vessel failure (TVF)	1-year	a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization

Secondary Outcome Measures

Name	Time	Method
Rate of BARC-defined bleeding	1-year	clinically-relevant bleeding event based on BARC classification
Rate of any myocardial infarction (MI)	1-year	myocardial infarction due to target vessel and non-target vessel failure
Rate of clinically-driven target vessel revascularization (TVR)	1-year	clinically-driven target vessel revascularization
Rate of all-cause mortality	1-year	cardiac and non-cardiac death
Rate of any revascularization	1-year	clinically-driven target lesion and non-target lesion revascularization
Rate of stent thrombosis (acute, subacute, late, very late)	1-year	stent thrombosis based on presenting time after the index procedure

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of