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Comparing CT-guided and IVUS-guided procedures for heart artery treatment

Precise Procedural and PCI Plan (P4) Randomized Clinical Trial Integration of Coronary Computed Tomography Angiography in the Catheterization Laboratory to Plan and Guide Coronary Percutaneous Procedures

NA · CoreAalst BV · NCT05253677

This study is testing whether using a CT scan or an ultrasound to guide heart artery treatment helps people with coronary artery disease have better results.

Quick facts

PhaseNA
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorCoreAalst BV (industry)
Locations17 sites (Jette, Brussels and 16 other locations)
Trial IDNCT05253677 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of two imaging strategies, coronary CT angiography (CCTA) and intravascular ultrasound (IVUS), in guiding percutaneous coronary interventions (PCI) for patients with coronary artery disease (CAD). Patients with significant coronary stenosis will be randomly assigned to receive either CT-guided or IVUS-guided PCI. The goal is to determine if the CT-guided approach can provide similar or better clinical outcomes compared to the traditional IVUS-guided method. This multicenter, randomized study aims to enhance patient selection and procedural planning in the catheterization laboratory.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with evidence of myocardial ischemia suitable for elective PCI.

Not a fit: Patients with severe high-risk features or those not suitable for PCI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the precision and outcomes of heart artery treatments for patients with coronary artery disease.

How similar studies have performed: Previous studies have shown promising results with imaging-guided PCI approaches, suggesting potential for success in this study.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Jette, Brussels and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Coronary Artery Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.