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)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Fundación EPIC
Study ID
NCT07286578
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 22, 2025
Status verified
Feb 2026
Primary completion
Dec 15, 2029
Completion
Jan 1, 2030

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CT-guide calcium modification strategy
    Pre-procedural CT will be used to determine lesion characteristics.
  • Active Comparator: IVUS-guide calcium modification strategy
    Pre-procedural IVUS will be used to determine lesion characteristics.

Primary Outcome Measure

Demonstrate that CT-guided calcium modification results in a superior final MSA Minimal Stent Area (MSA) - Imaging Endpoint (Superiority) [ Time Frame: Perioperative/Periprocedural ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Bringham and Women's HospitalBostonMassachusetts02115-
Minneapolis Heart InstituteMinneapolisMinnesota55407-
HACKENSACK MERIDIAN HEALTH, IncJersey CityNew Jersey08837-
Columbia University Irving Medical Center/NewYork-Presbyterian HospitalNew YorkNew York10032-
Weill Medical College of Cornell UniversityNew YorkNew York14853-

Find similar trials in Boston, MA

By research site
Bringham and Women's Hospital· Boston, MAMinneapolis Heart Institute· Minneapolis, MNHACKENSACK MERIDIAN HEALTH, Inc· Jersey City, NJColumbia University Irving Medical Center/NewYork-Presbyterian Hospital· New York, NYWeill Medical College of Cornell University· New York, NY

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