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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)

Sponsor: Fundación EPIC

NCT ID: NCT07286578

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
CT(Computed Tomography) guided Percutaneous Coronary Intervention (device), IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention (device)
How long the study runs
Study runs about 49 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 85 Years
Who
All
Number of participants
700
Started
2025-12-22
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for cardiovascular diseases
  • • NA - 700 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 85 Years
  • • Diagnosed with cardiovascular diseases

Where?

  • • Leicester - University Hospitals of Leicester NHS Trust
  • • London - St Bartholomew's Hospital (Barts Health NHS Trust)
  • • London - St George's University Hospitals NHS Foundations Trust
  • • Newcastle - Newcastle Hospitals NHS Foundations Trust
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

The OPTIMAL Trial is a prospective, multicenter, randomized controlled study evaluating whether a coronary CT angiography (CCTA)-guided calcium modification strategy can improve the treatment of patients with hemodynamically significant, calcified coronary artery disease undergoing percutaneous coronary intervention (PCI). Seven hundred patients with flow-limiting stenosis (FFRCT ≤0.80) and moderate-to-severe calcification on CCTA will be randomized 1:1 to either CCTA-guided or intravascular ultrasound (IVUS)-guided calcium modification. The study includes two co-primary endpoints: (1) superiority in final minimal stent area assessed by IVUS, and (2) non-inferiority in 12-month target vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven revascularization). CCTA-guided strategy uses advanced calcium characterization to inform pre-procedural planning and selection of plaque modification techniques. IVUS-guided strategy follows contemporary intravascular imaging-based criteria for plaque preparation and PCI optimization. The trial aims to determine whether leveraging non-invasive CT-based calcium assessment can enhance procedural efficiency and stent results while maintaining clinical safety comparable to IVUS-guided PCI.

Cardiovascular DiseasesMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCoronary Artery Disease

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 85 Years
  • Who can join: All genders

Biomarkers mentioned

have a negative

Treatment history

Treatments you must have had:

  • ✓ evidence of myocardial ischemia (e
  • ✓ reference vessel diameter (visually assessed by CCTA) ≥ 2

What the study is looking for

  • ✓The subject must be at least 18 years of age and younger than 85 years old
  • ✓All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm
  • ✓Subject must provide written agreement to take part before any study-related procedure

Who cannot take part

  • ✗STEMI as the clinical presentation.
  • ✗Uncontrolled or recurrent ventricular tachycardia.
  • ✗Hemodynamic instability.
  • ✗Hemodialysis or peritoneal dialysis.
  • ✗Left main coronary artery stenosis \> 50%
See the full 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 Is This Study? (5 UK sites)

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

St Bartholomew's Hospital (Barts Health NHS Trust)

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

St George's University Hospitals NHS Foundations Trust

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

Newcastle Hospitals NHS Foundations Trust

Newcastle, United Kingdom

NOT_YET_RECRUITING

John Radcliffe Hospital, Oxford

Oxford, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

How to Get in Touch

CAROLINA FOCELLA

Sponsor contact

CONTACT

001 917 753 6695 cfocella@crf.org

CARLOS COLLET, MD,PhD

Sponsor contact

CONTACT

001 917 753 6695 carloscollet@gmail.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09