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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (5 UK sites)
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351St Bartholomew's Hospital (Barts Health NHS Trust)
London, United Kingdom
St George's University Hospitals NHS Foundations Trust
London, United Kingdom
Newcastle Hospitals NHS Foundations Trust
Newcastle, United Kingdom
John Radcliffe Hospital, Oxford
Oxford, United Kingdom
How to Get in Touch
CAROLINA FOCELLA
Sponsor contactCONTACT
CARLOS COLLET, MD,PhD
Sponsor contactCONTACT
