Measurement of Hyperemic Pullback Pressure Gradients to Characterize Patterns of Coronary Atherosclerosis.
Carlos Collet, Jeroen Sonck, Bert Vandeloo...
https://pubmed.ncbi.nlm.nih.gov/31582137Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID07286578
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium
Led by Fundación EPIC · Updated on 2026-02-10
700
Participants Needed
13
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate two imaging strategies for treating patients with significant calcified coronary artery disease. The trial compares a calcium modification approach guided by coronary CT angiography (CCTA) to the current standard of care using intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI). The goal is to see if the CCTA method can improve procedural efficiency and effectiveness while maintaining similar clinical outcomes. Participants will be randomly assigned to one of two groups: one using CCTA to guide calcium modification and lesion assessment before PCI, and the other using IVUS for lesion evaluation and PCI guidance. The CCTA group uses advanced CT imaging to plan plaque modification, while the IVUS group follows established intravascular ultrasound criteria. Both groups undergo post-procedural IVUS to confirm correct stent placement. During the study, participants will undergo imaging evaluations such as CCTA and IVUS scans to assess lesion characteristics and stent results. Researchers will monitor procedural efficiency measures including procedure time, radiation exposure, and contrast use. Clinical outcomes like target vessel failure, myocardial infarction, and stent thrombosis will be tracked for up to 12 months. Patient-reported angina symptoms will also be collected to evaluate treatment impact. The total participation spans from pre-procedural planning through a 12-month follow-up.
CONDITIONS
Brief Title
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)
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Participants must be between 18 and 85 years old
- Evidence of myocardial ischemia suitable for PCI, including stable or unstable angina, silent ischemia, or acute myocardial infarction
- Clinical indication for revascularization with stable coronary artery disease or stabilized acute coronary syndrome
- All target vessels must have a reference diameter of at least 2.5 mm by coronary CT angiography
- Ability to provide written informed consent before any study procedure
You will not qualify if you...
- STEMI as the clinical presentation
- Uncontrolled or recurrent ventricular tachycardia
- Hemodynamic instability
- Receiving hemodialysis or peritoneal dialysis
- Left main coronary artery stenosis greater than 50%
- Atrial fibrillation, flutter, or arrhythmias during CT acquisition
- Previous PCI in the target vessel or coronary artery bypass grafting
- Body mass index of 40 kg/m2 or higher
- Insufficient CT image quality
- Comorbidities with life expectancy of 2 years or less
- Planned major cardiac or non-cardiac surgery within 24 months after the procedure
- Solid organ transplant recipients or candidates with expected transplant within 24 months
- Use of immunosuppressive therapy or severe autoimmune diseases requiring chronic immunosuppression
- Previous or planned radiotherapy to coronary arteries or chest
- Platelet count below 100,000 or above 700,000 cells/mm3
- Documented or suspected liver cirrhosis or Child-Pugh class B or higher
- History of bleeding disorders or recent significant bleeding
- Recent cerebrovascular accident, transient ischemic attack, intracranial bleed, or known intracranial pathology
- Participation in another investigational drug or device trial
- Pregnant or nursing, or planning pregnancy within 2 years
- Other medical, social, or psychological conditions that limit participation or compliance
- Inability to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of procedure
Participants undergo either CT-guided or IVUS-guided percutaneous coronary intervention to treat calcified coronary artery disease, with imaging used to guide and confirm stent placement.
1 procedure visit (in-person)
Follow-up
Duration - Up to 12 months
Participants are monitored for clinical outcomes, stent performance, and safety for up to 12 months after the intervention.
Approximately 3 to 4 follow-up visits
Trial Site Locations
Total: 13 locations
1
Bringham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
2
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Not Yet Recruiting
3
HACKENSACK MERIDIAN HEALTH, Inc
Jersey City, New Jersey, United States, 08837
Not Yet Recruiting
4
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
New York, New York, United States, 10032
Not Yet Recruiting
5
Weill Medical College of Cornell University
New York, New York, United States, 14853
Not Yet Recruiting
6
Hospital Universitari Vall Hebron
Barcelona, Spain, 08035
Actively Recruiting
7
Hospital Universitario de Leon
León, Spain
Actively Recruiting
8
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
9
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Not Yet Recruiting
10
St Bartholomew's Hospital (Barts Health NHS Trust)
London, United Kingdom
Not Yet Recruiting
11
St George's University Hospitals NHS Foundations Trust
London, United Kingdom
Not Yet Recruiting
12
Newcastle Hospitals NHS Foundations Trust
Newcastle, United Kingdom
Not Yet Recruiting
13
John Radcliffe Hospital, Oxford
Oxford, United Kingdom
Not Yet Recruiting
Loading map...
Research Team
C
CAROLINA FOCELLA
C
CARLOS COLLET, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Advanced CT Imaging for the Assessment of Calcific Coronary Artery Disease and PCI Planning.
Atomu Tajima, Frederic Bouisset, Hirofumi Ohashi...
https://pubmed.ncbi.nlm.nih.gov/39131223Quantification of calcium burden by coronary CT angiography compared to optical coherence tomography.
G Monizzi, J Sonck, S Nagumo...
https://pubmed.ncbi.nlm.nih.gov/33205340Clinical Validation of a Virtual Planner for Coronary Interventions Based on Coronary CT Angiography.
Jeroen Sonck, Sakura Nagumo, Bjarne L Norgaard...
https://pubmed.ncbi.nlm.nih.gov/35798401Differential Improvement in Angina and Health-Related Quality of Life After PCI in Focal and Diffuse Coronary Artery Disease.
Carlos Collet, Damien Collison, Takuya Mizukami...
https://pubmed.ncbi.nlm.nih.gov/36543445