RecruitingNot ApplicableNCT07286578

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


Sponsor

Fundación EPIC

Enrollment

700 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called CT(Computed Tomography) guided Percutaneous Coronary Intervention and a medical device called IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention for people with arterial occlusive diseases, arteriosclerosis, and other related conditions. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 Hospital

Boston, Massachusetts, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

HACKENSACK MERIDIAN HEALTH, Inc

Jersey City, New Jersey, United States

Columbia University Irving Medical Center/NewYork-Presbyterian Hospital

New York, New York, United States

Weill Medical College of Cornell University

New York, New York, United States

Hospital Universitari Vall Hebron

Barcelona, Spain

Hospital Universitario de Leon

León, Spain

Hospital Universitario La Paz

Madrid, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07286578


Related Trials