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The OPTIMAL Trial: Improving Treatment for Calcified Heart Disease

This study, called The OPTIMAL Trial, is looking at better ways to treat coronary artery disease where there's a lot of calcium buildup in the heart's arteries. It compares two methods for guiding a procedure called percutaneous coronary intervention (PCI), which involves placing a stent to open blocked arteries. One method uses CT (Computed Tomography) scans to plan the procedure, and the other uses IVUS (Intravascular Ultrasound) during the procedure. The goal is to see if using CT scans to guide calcium modification leads to better stent placement and similar long-term results compared to the current standard IVUS-guided approach. You might be able to join if you are between 18 and 85 years old and have evidence of myocardial ischemia (reduced blood flow to the heart muscle) suitable for PCI. The study is currently enrolling 700 participants.

Study design
This is a randomized controlled study, meaning participants will be randomly assigned to one of two treatment groups. It plans to enroll 700 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after their procedure to check for target vessel failure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07286578

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)

Recruiting
NAAges 18–85InterventionalTreatment
Fundación EPIC
~700 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:CT(Computed Tomography) guided Percutaneous Coronary InterventionIVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention

At a glance

Recruiting sites
8 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demonstrate that CT-guided calcium modification results in a superior final MSA Minimal Stent Area (MSA) - Imaging Endpoint (Superiority)
Measured over Perioperative/Periprocedural
+1 more outcome measured

Conditions

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

Explore related trials

Coronary Artery Disease

Where it's being run

14 sites across 7 states
United Kingdom5
Spain3
New York2
Massachusetts1
Minnesota1
New Jersey1
Belgium1

Who to contact

CAROLINA FOCELLA
[email protected]
001 917 753 6695
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

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

    Final post-PCI minimal stent area per target lesion, measured by independent core laboratory using intravascular ultrasound (IVUS). Assesses whether CT-guided calcium modification results in superior stent expansion compared with IVUS-guided PCI.

  • Target Vessel Failure (TVF) - Clinical Endpoint (Non-Inferiority)12 months

    Composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR). TV-MI and ID-TVR are defined according to ARC-2 and the Fourth Universal Definition of MI.