Recruiting

CCTA vs. IVUS

Sponsor:

Fundación EPIC

Code:

NCT07286578

Conditions

Cardiovascular Diseases

Myocardial Ischemia

Heart Diseases

Arteriosclerosis

Arterial Occlusive Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CT(Computed Tomography) guided Percutaneous Coronary Intervention

IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention

Study Details

Brief 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

Cardiovascular Diseases

Myocardial Ischemia

Heart Diseases

Arteriosclerosis

Arterial Occlusive Diseases

Study ID

NCT07286578

Start date

Dec 22, 2025

Status verified date

Sep, 2026

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Dec 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The subject must be at least 18 years of age and younger than 85 years old
  • Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for PCI. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression>1mm in ≥6 leads plus STsegment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score>140.
  • All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm
  • Subject must provide written informed consent before any study-related procedure

Exclusion Criteria:

  • STEMI as the clinical presentation.
  • Uncontrolled or recurrent ventricular tachycardia.
  • Hemodynamic instability.
  • Hemodialysis or peritoneal dialysis.
  • Left main coronary artery stenosis > 50%
  • Atrial fibrillation, flutter, or arrhythmias during CT acquisition.
  • Previous PCI in the target vessel or CABG.
  • BMI ≥ 40 kg/m2
  • Insufficient CT quality assessed by the Core lab.
  • Comorbidity with life expectancy ≤ 2 years.
  • Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.
  • The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
  • The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
  • The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.
  • Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
  • The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  • The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy <2 years for any non-cardiac cause.
  • Subject is currently participating in another investigational drug or device clinical study.
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • Unable to provide written informed consent (IC).

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

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

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 ]
  • Target Vessel Failure (TVF) - Clinical Endpoint (Non-Inferiority) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

CAROLINA FOCELLA

001 917 753 6695cfocella@crf.org

CARLOS COLLET, MD,PhD

001 917 753 6695carloscollet@gmail.com

Locations

Minneapolis Heart Institute

Recruiting

Minneapolis, Minnesota, United States, 55407

More Information

Sponsor

Fundación EPIC

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • IVUS
  • CT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Fundación EPIC on 2026-09-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.