Clinical Trial

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)

Recruiting
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-12-12; most recent amendment 2026-07-07.
Status change: Not Yet Recruiting → Recruiting 2025-12-29
Trial Details
NCT Number NCT07286578
Lead Sponsor Fundación EPIC
Conditions Cardiovascular Diseases, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases, Coronary Artery Disease
Enrollment 700 participants
Start Date 2025-12-22
Primary Completion 2029-12-15 (estimated)
Study Completion 2030-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-10