The OPTIMAL randomized clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.
The subject must be at least 18 years of age and younger than 85 years old
Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for PCI. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression>1mm in ≥6 leads plus STsegment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score>140.
All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm
Subject must provide written informed consent before any study-related procedure
STEMI as the clinical presentation.
Uncontrolled or recurrent ventricular tachycardia.
Hemodynamic instability.
Hemodialysis or peritoneal dialysis.
Parallel
CT(Computed Tomography) guided Percutaneous Coronary Intervention
DeviceCT will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent
IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention
DeviceIVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent
Demonstrate that CT-guided calcium modification results in a superior final MSA Minimal Stent Area (MSA) - Imaging Endpoint (Superiority)
Final post-PCI minimal stent area per target lesion, measured by independent core laboratory using intravascular ultrasound (IVUS). Assesses whether CT-guided calcium modification results in superior stent expansion compared with IVUS-guided PCI.
Target Vessel Failure (TVF) - Clinical Endpoint (Non-Inferiority)
Composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR). TV-MI and ID-TVR are defined according to ARC-2 and the Fourth Universal Definition of MI.
Procedural efficiency: Procedure time
Time from first angiogram to final angiogram
Procedural efficiency:Radiation dose-area product
Dose-area product (DAP) recorded during PCI.
Procedural efficiency: Contrast volume
Total contrast volume (mL) used during PCI.IVUS-Derived Mechanistic Endpoints (Core Lab)
Procedural Efficiency: Stent Area on Immediate Post-Stent IVUS
MSA prior to any final IVUS-guided optimization.
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Fundación EPIC
Lead sponsor
Cardiovascular Research Foundation, New York
Collaborator
St George's University Hospitals NHS Foundation Trust
Collaborator
