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Recruiting Not applicable

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)

NCT07286578 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2025-12-22
Last updated
2026-09-28

Condition(s) studied

Cardiovascular DiseasesMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCoronary Artery Disease

Investigational drug(s) / intervention(s)

CT(Computed Tomography) guided Percutaneous Coronary InterventionIVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • 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.

Trial sites (14)

FacilityCityRegionStatus
Bringham and Women's Hospital Boston Massachusetts Not Yet Recruiting
Minneapolis Heart Institute Minneapolis Minnesota Recruiting
HACKENSACK MERIDIAN HEALTH, Inc Jersey City New Jersey Not Yet Recruiting
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital New York New York Not Yet Recruiting
Weill Medical College of Cornell University New York New York Not Yet Recruiting
Azorg Hospital, Aalst Aalst Belgium 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 Recruiting
St Bartholomew's Hospital (Barts Health NHS Trust) London United Kingdom Recruiting
St George's University Hospitals NHS Foundations Trust London United Kingdom Recruiting
Newcastle Hospitals NHS Foundations Trust Newcastle United Kingdom Not Yet Recruiting
John Radcliffe Hospital, Oxford Oxford United Kingdom Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07286578 on ClinicalTrials.gov ↗ ← All trials in Belgium