NCT07286578

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)

A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Fundación EPIC · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases
• Myocardial Ischemia
• Heart Diseases
• Arteriosclerosis
• Arterial Occlusive Diseases
• Vascular Diseases
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	CT(Computed Tomography) guided Percutaneous Coronary Intervention	CT will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent
DEVICE	IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention	IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent

Timeline

• Start date: 2025-12-22
• Primary completion: 2029-12-15
• Completion: 2030-01-01
• First posted: 2025-12-16
• Last updated: 2026-02-10

Locations

13 sites across 3 countries: United States, Spain, United Kingdom