Heart artery showdown: CT vs ultrasound for stent placement
NCT ID NCT05253677
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether using a CT scan before and during a heart artery procedure (PCI) works as well as the standard ultrasound method (IVUS). About 1,090 patients with narrowed heart arteries will be randomly assigned to one of the two imaging methods. The main goal is to see if the CT-guided approach leads to similar rates of heart attacks, heart-related death, or repeat procedures within one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CT-guided PCI (device) and IVUS-guided PCI (device)
- What this could lead to
- If CT guidance works as well as IVUS, it could simplify planning for heart artery procedures and reduce costs.
- What could go wrong
- This is a non-inferiority trial, so CT may not prove better—just not worse. Results are limited to stable patients and may not apply to emergencies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,090 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The subject must be at least 18 years of age and younger than 80 years old. 2. 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 elective PCI. 3. 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 ST-segment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score\>140. 4. All target lesions must be planned for treatment only in vessels with RVD ≥2.5 mm and ≤4.0 mm. 5. No more than 2 target vessels are allowed. A bifurcation counts as a single lesion even if the side branch is planned to be treated. 6. Subject must provide written Informed Consent before any study-related procedure. Exclusion Criteria: 1. Age \<18 years or ≥80 years old 2. STEMI as clinical presentation. 3. Uncontrolled or recurrent ventricular tachycardia. 4. Hemodynamic instability. 5. Severe renal dysfunction, defined as an eGFR ≤30 mL/min/1.73 m2. 6. Atrial fibrillation, flutter, or arrhythmias. 7. Previous PCI or CABG. 8. The target lesion is in the left main coronary artery 9. BMI ≥35 kg/m2. 10. Insufficient CT quality assessed by the Core lab. 11. Comorbidity with life expectancy ≤ 2 years. 12. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in the patient presenting with an ACS, or at least 6 months in the patient presenting with stable CAD, unless the patient is also taking chronic oral anticoagulation in which case a shorter duration of DAPT may be prescribed per local standard of care. 13. 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. 14. Prior PCI within the target vessel within 12 months. 15. Subject has known hypersensitivity or contraindication to any of the study drugs (including all P2Y12 inhibitors, one or more components of the study devices, including everolimus, zotarolimus, biolimus, sirolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoropolymers, or radiocontrast dye that cannot be adequately pre-medicated. 16. 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. 17. 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. 18. The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum. 19. Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3. 20. The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B. 21. 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. 22. Subject is currently participating in another investigational drug or device clinical study. 23. 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. 24. 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. 25. Unable to provide written informed consent (IC).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aarhus Universitetshospital
Aarhus, 8200, Denmark
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Aichi Medical University
Aichi, Japan
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Azienda Ospedaliero Universitaria di Ferrara
Cona, 44124, Italy
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Barts Health NHS Trust
London, E1 1FR, United Kingdom
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Centre Hospitalier Universitaire de Lille
Lille, 59037, France
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Centro Cardiologico Monzino S.P.A.
Milan, Italy
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Freeman Hospital
Newcastle, NE7 7DN, United Kingdom
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Gentofte hospital
Gentofte Municipality, Hellerup, 2900, Denmark
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Golden Jubilee National Hospital
Clydebank, G81 4DY,, United Kingdom
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Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
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Hartcentrum ZNA Antwerp
Antwerp, 2000, Belgium
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Humanitas University
Milan, 20090, Italy
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Liverpool Heart and Chest Hospital
Liverpool, L14 3PE, United Kingdom
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Medical Imaging Centre, Semmelweis University
Budapest, 1082, Hungary
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Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
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OLV Hospital
Aalst, 9300, Belgium
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Ospedale Galeazzi Sant'Ambrogio
Milan, 20149, Italy
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Rigshospitalet
Copenhagen, 2100, Denmark
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St George's University Hospitals NHS Foundation Trust
London, ,SW17 0QT, United Kingdom
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St. Francis Hospital & Heart Center
Roslyn, New York, 11576, United States
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UZ Brussels
Jette, Brussels Capital, 1090, Belgium
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University Hospitals Dorset NHS Foundation Trust, Poole Hospital
Poole, Dorset, BH15 2JB, United Kingdom
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