A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Fundación EPIC
- Enrollment
- 700
- Locations
- 13
- Primary Endpoint
- Demonstrate that CT-guided calcium modification results in a superior final MSA Minimal Stent Area (MSA) - Imaging Endpoint (Superiority)
Overview
Brief Summary
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.
Detailed Description
The OPTIMAL Trial is a prospective, multicenter, randomized controlled study evaluating whether a coronary CT angiography (CCTA)-guided calcium modification strategy can improve the treatment of patients with hemodynamically significant, calcified coronary artery disease undergoing percutaneous coronary intervention (PCI).
Seven hundred patients with flow-limiting stenosis (FFRCT ≤0.80) and moderate-to-severe calcification on CCTA will be randomized 1:1 to either CCTA-guided or intravascular ultrasound (IVUS)-guided calcium modification. The study includes two co-primary endpoints: (1) superiority in final minimal stent area assessed by IVUS, and (2) non-inferiority in 12-month target vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven revascularization).
CCTA-guided strategy uses advanced calcium characterization to inform pre-procedural planning and selection of plaque modification techniques. IVUS-guided strategy follows contemporary intravascular imaging-based criteria for plaque preparation and PCI optimization.
The trial aims to determine whether leveraging non-invasive CT-based calcium assessment can enhance procedural efficiency and stent results while maintaining clinical safety comparable to IVUS-guided PCI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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\>
- •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
Exclusion Criteria
- •STEMI as the clinical presentation.
- •Uncontrolled or recurrent ventricular tachycardia.
- •Hemodynamic instability.
- •Hemodialysis or peritoneal dialysis.
- •Left main coronary artery stenosis \> 50%
- •Atrial fibrillation, flutter, or arrhythmias during CT acquisition.
- •Previous PCI in the target vessel or CABG.
- •BMI ≥ 40 kg/m2
- •Insufficient CT quality assessed by the Core lab.
- •Comorbidity with life expectancy ≤ 2 years.
Arms & Interventions
CT-guide calcium modification strategy
Pre-procedural CT will be used to determine lesion characteristics.
Intervention: CT(Computed Tomography) guided Percutaneous Coronary Intervention (Device)
IVUS-guide calcium modification strategy
Pre-procedural IVUS will be used to determine lesion characteristics.
Intervention: IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention (Device)
Outcomes
Primary Outcomes
Demonstrate that CT-guided calcium modification results in a superior final MSA Minimal Stent Area (MSA) - Imaging Endpoint (Superiority)
Time Frame: Perioperative/Periprocedural
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)
Time Frame: 12 months
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.
Secondary Outcomes
- Procedural Efficiency: Change in Plaque Attenuation(Post-modification, pre-stent)
- Procedural Efficiency: Final Minimal Lumen Diameter(Perioperative/Periprocedural)
- Patient-Reported Outcomes: Residual Angina (SAQ-7 Angina Frequency)(12 months)
- Patient-Reported Outcomes: Change in Angina (SAQ-7)(Baseline to 12 months)
- Procedural efficiency: Procedure time(During PCI)
- Procedural efficiency:Radiation dose-area product(During PCI)
- Procedural efficiency: Contrast volume(During PCI)
- Procedural Efficiency: Stent Area on Immediate Post-Stent IVUS(Perioperative/Periprocedural)
- Procedural Efficiency: Final Stent Area at Original Minimal Lumen Area (MLA)(Perioperative/Periprocedural)
- Procedural Efficiency: Final Stent Area at Site of Maximum Calcium Arc(Perioperative/Periprocedural)
- Procedural Efficiency: Final Stent Area at Site of Maximum Calcium Density(Perioperative/Periprocedural)
- Procedural Efficiency: Relative Stent Expansion(Perioperative/Periprocedural)
- Procedural Efficiency: Number of Calcium Fractures(Post-modification, pre-stent)
- Procedural Efficiency: Final Percent Diameter Stenosis(Perioperative/Periprocedural)
- Procedural Efficiency: Final TIMI Flow Grade(Perioperative/Periprocedural)
- Clinical & Safety Outcomes: Procedural Success(Perioperative/Periprocedural)
- Clinical & Safety Outcomes: Periprocedural Myocardial Infarction (Type 4a MI)(Day 0-1)
- Clinical & Safety Outcomes: Stent Thrombosis(Up to 12 months)
- Procedural Efficiency: Angiographic Complications(Day of procedure)