Concurrent OCT and FFR-guided PCI in CAD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Concurrent OPTIcal Coherence Tomography and frActional Flow REserve-guided Therapeutic Intervention in Patients With Coronary Artery Disease (OPTICARE-CAD)

Conditions
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Coronary Artery Disease, Image, Atheroscleroses, Coronary

Intervention / Treatment
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* Diagnostic Test: optical coherence tomography and fractional flow reserve
* Diagnostic Test: Coronary angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 19 years old Patients undergoing coronary stent implantation for stable angina or acute coronary syndrome Patients provided on informed consent Exclusion Criteria: Individuals with a history of increased bleeding tendencies or hematologic disorders Presented with refractory cardiogenic shock Individuals with a history of stent thrombosis Expected life expectancy of less than 1 year Left ventricular ejection fraction (LVEF) ≥ 20% Women who are breastfeeding, pregnant, or planning to become pregnant Deemed unsuitable for participation by the investigator Patients unwilling to participate in the clinical trial

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized open-label clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Angiography-guided PCI group<br>This group of patients are intended to undergo PCI with conventional angiography-guidance. Procedural optimization determined by angiographic assessment. | Diagnostic Test: Coronary angiography<br>* The assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography<br>|
| Experimental: Concurrent OCT/FFR-guided PCI group<br>This group of patients are intended to undergo PCI with concurrent OCT/FFR-guidance. Procedural optimization determined by OCT and FFR assessment. | Diagnostic Test: optical coherence tomography and fractional flow reserve<br>* The assessment of pre-procedural lesions and optimization status of implanted stents will involve both intracoronary imaging and physiological indices.<br>Diagnostic Test: Coronary angiography<br>* The assessment of pre-procedural lesions and optimization status of implanted stents will be determined by conventional coronary angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of target vessel failure (TVF) | a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization | 1-year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical coherence tomography, Fractional flow reserve, Angiography, Coronary artery disease, Percutaneous coronary intervention, Drug-eluting stent