Concurrent OPTIcal Coherence Tomography and frActional Flow REserve-guided Therapeutic Intervention in Patients With Coronary Artery Disease (OPTICARE-CAD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Rate of target vessel failure (TVF)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
No blinding process, open label design
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Angiography-guided PCI group
This group of patients are intended to undergo PCI with conventional angiography-guidance. Procedural optimization determined by angiographic assessment.
Intervention: Coronary angiography (Diagnostic Test)
Concurrent OCT/FFR-guided PCI group
This group of patients are intended to undergo PCI with concurrent OCT/FFR-guidance. Procedural optimization determined by OCT and FFR assessment.
Intervention: optical coherence tomography and fractional flow reserve (Diagnostic Test)
Concurrent OCT/FFR-guided PCI group
This group of patients are intended to undergo PCI with concurrent OCT/FFR-guidance. Procedural optimization determined by OCT and FFR assessment.
Intervention: Coronary angiography (Diagnostic Test)
Outcomes
Primary Outcomes
Rate of target vessel failure (TVF)
Time Frame: 1-year
a composite endpoint of cardiac death, target vessel-related non-fatal myocardial infarction, clinically driven-target vessel revascularization
Secondary Outcomes
- Rate of any myocardial infarction (MI)(1-year)
- Rate of clinically-driven target vessel revascularization (TVR)(1-year)
- Rate of all-cause mortality(1-year)
- Rate of any revascularization(1-year)
- Rate of stent thrombosis (acute, subacute, late, very late)(1-year)
- Rate of BARC-defined bleeding(1-year)
Investigators
Kang Dong Oh
Assistant Professor
Korea University Guro Hospital