A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Start Date
12/22/2025
Completion Date
1/1/2030
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.
Eligibility Criteria
Age Range: 18 years to 85 years
Interventions
CT(Computed Tomography) guided Percutaneous Coronary Intervention
IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention
Conditions
Locations
Bringham and Women's Hospital
Boston, Massachusetts 02115
United States
Minneapolis Heart Institute
Minneapolis, Minnesota 55407
United States
HACKENSACK MERIDIAN HEALTH, Inc
Jersey City, New Jersey 08837
United States
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
New York, New York 10032
United States
Weill Medical College of Cornell University
New York, New York 14853
United States
Hospital Universitari Vall Hebron
Barcelona, 08035
Spain
Hospital Universitario de Leon
León,
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
University Hospitals of Leicester NHS Trust
Leicester,
United Kingdom
St Bartholomew's Hospital (Barts Health NHS Trust)
London,
United Kingdom
St George's University Hospitals NHS Foundations Trust
London,
United Kingdom
Newcastle Hospitals NHS Foundations Trust
Newcastle,
United Kingdom
John Radcliffe Hospital, Oxford
Oxford,
United Kingdom