Coronary CT angiography–guided calcium modification during PCI for calcified coronary artery disease

A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium

This study will see if using CT angiography to plan calcium treatment before stenting helps people with flow-limiting, calcified coronary artery disease have better stent results and faster procedures compared with the usual ultrasound-guided PCI while keeping similar safety.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 700 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Fundación EPIC (other)
• Locations: 13 sites (Boston, Massachusetts and 12 other locations)
• Trial ID: NCT07286578 on ClinicalTrials.gov

What this trial studies

OPTIMAL is a prospective, multicenter, randomized trial enrolling 700 patients with flow-limiting stenosis (FFRCT ≤ 0.80) and moderate-to-severe coronary calcification on CCTA, randomized 1:1 to CCTA-guided versus IVUS-guided calcium modification before PCI. The CCTA-guided arm uses advanced CT-based calcium characterization to inform pre-procedural planning and choice of plaque-modification techniques, while the comparator arm follows contemporary intravascular ultrasound criteria for plaque preparation and stent optimization. The trial has two co-primary endpoints: superiority for final minimal stent area measured by IVUS and non-inferiority for 12-month target vessel failure (cardiac death, target-vessel MI, or ischemia-driven revascularization). The goal is to determine whether a noninvasive CT-based planning approach can improve procedural efficiency and stent expansion without worsening clinical outcomes.

Who should consider this trial

Good fit: Adults 18–84 with hemodynamically significant (FFRCT ≤ 0.80) coronary stenosis and moderate-to-severe calcification on CCTA, with target vessel diameter ≥ 2.5 mm and a clinical indication for PCI, are ideal candidates.

Not a fit: Patients with minimal or no coronary calcification, target vessels under 2.5 mm, unstable high-risk myocardial infarction, or who cannot undergo CCTA or intravascular imaging are unlikely to benefit from the study intervention.

Why it matters

Potential benefit: If successful, CT-guided planning could produce larger final stent areas and more efficient PCI procedures using noninvasive imaging while maintaining similar clinical safety.

How similar studies have performed: Intravascular imaging–guided PCI using IVUS is an established approach, but using CCTA to direct calcium modification is a newer strategy with limited randomized evidence to date.

Eligibility criteria

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).

Where this trial is running

Boston, Massachusetts and 12 other locations

• Bringham and Women's Hospital — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States (NOT_YET_RECRUITING)
• HACKENSACK MERIDIAN HEALTH, Inc — Jersey City, New Jersey, United States (NOT_YET_RECRUITING)
• Columbia University Irving Medical Center/NewYork-Presbyterian Hospital — New York, New York, United States (NOT_YET_RECRUITING)
• Weill Medical College of Cornell University — New York, New York, United States (NOT_YET_RECRUITING)
• Hospital Universitari Vall Hebron — Barcelona, Spain (RECRUITING)
• Hospital Universitario de Leon — León, Spain (RECRUITING)
• Hospital Universitario La Paz — Madrid, Spain (RECRUITING)
• University Hospitals of Leicester NHS Trust — Leicester, United Kingdom (NOT_YET_RECRUITING)
• St Bartholomew's Hospital (Barts Health NHS Trust) — London, United Kingdom (NOT_YET_RECRUITING)
• St George's University Hospitals NHS Foundations Trust — London, United Kingdom (NOT_YET_RECRUITING)
• Newcastle Hospitals NHS Foundations Trust — Newcastle, United Kingdom (NOT_YET_RECRUITING)
• John Radcliffe Hospital, Oxford — Oxford, United Kingdom (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: CAROLINA FOCELLA

Conditions: Cardiovascular Diseases, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases, Coronary Artery Disease, IVUS