A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium
Fundación EPIC
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.
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) superi…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- 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 s…
Interventions
- DeviceCT(Computed Tomography) guided Percutaneous Coronary Intervention
CT will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent
- DeviceIVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention
IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent
Locations (13)
- Bringham and Women's HospitalBoston, Massachusetts
- Minneapolis Heart InstituteMinneapolis, Minnesota
- HACKENSACK MERIDIAN HEALTH, IncJersey City, New Jersey
- Columbia University Irving Medical Center/NewYork-Presbyterian HospitalNew York, New York
- Weill Medical College of Cornell UniversityNew York, New York
- Hospital Universitari Vall HebronBarcelona