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Heart artery showdown: CT vs ultrasound for stent placement

NCT ID NCT05253677

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 1,090 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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

  • Aarhus Universitetshospital

    Aarhus, 8200, Denmark

  • Aichi Medical University

    Aichi, Japan

  • Azienda Ospedaliero Universitaria di Ferrara

    Cona, 44124, Italy

  • Barts Health NHS Trust

    London, E1 1FR, United Kingdom

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Universitaire de Lille

    Lille, 59037, France

  • Centro Cardiologico Monzino S.P.A.

    Milan, Italy

  • Freeman Hospital

    Newcastle, NE7 7DN, United Kingdom

  • Gentofte hospital

    Gentofte Municipality, Hellerup, 2900, Denmark

  • Golden Jubilee National Hospital

    Clydebank, G81 4DY,, United Kingdom

  • Guy's and St Thomas' NHS Foundation Trust

    London, United Kingdom

  • Hartcentrum ZNA Antwerp

    Antwerp, 2000, Belgium

  • Humanitas University

    Milan, 20090, Italy

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE, United Kingdom

  • Medical Imaging Centre, Semmelweis University

    Budapest, 1082, Hungary

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • OLV Hospital

    Aalst, 9300, Belgium

  • Ospedale Galeazzi Sant'Ambrogio

    Milan, 20149, Italy

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • St George's University Hospitals NHS Foundation Trust

    London, ,SW17 0QT, United Kingdom

  • St. Francis Hospital & Heart Center

    Roslyn, New York, 11576, United States

  • UZ Brussels

    Jette, Brussels Capital, 1090, Belgium

  • University Hospitals Dorset NHS Foundation Trust, Poole Hospital

    Poole, Dorset, BH15 2JB, United Kingdom

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