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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)

NCT07286578 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Fundación EPIC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2029-12-15
Completion
2030-01-01

Countries

  • United States
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286578 on ClinicalTrials.gov