CT vs IVUS-Guided PCI for Coronary Artery Disease
(P4 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Computed tomography (CT) has become an established tool in the diagnostic workup of patients with suspected coronary artery disease (CAD). The availability of coronary CT angiography (CCTA) before the invasive procedure allows stratifying case complexity and can be used to improve patient selection for PCI, to plan and guide therapeutic interventions. Beyond the diagnostic and therapeutic phase, it helps to better organize the catheterization laboratory workflow.
The P4 study is an investigator-initiated, multicenter, randomized study with a non-inferiority design of patients with an indication for PCI aiming at comparing clinical outcomes between two imaging strategies to guide PCI, being coronary CT-guided PCI strategy (investigational technology) and IVUS-guided PCI strategy (comparator).
After identifying the presence of a significant coronary stenosis, the patient will be randomized either to CT- or IVUS-guided PCI groups. Both CT and IVUS-guided PCI will be performed following the P4 trial protocol. When the procedure is completed, post-PCI FFR will be measured. All patients will be followed in hospital, at 30 days (±15 days), 12 months (±1 month) and yearly until 5 year.
Who Is on the Research Team?
Carlos Collet Bortone, MD, PhD
Principal Investigator
CoreAalst BV
Daniele Andreini, MD, PhD
Principal Investigator
Milan University, Milan, Italy
Are You a Good Fit for This Trial?
This trial is for patients with myocardial ischemia or stable coronary artery disease suitable for elective PCI. It includes those with unstable angina, NSTEMI without high-risk features, and lesions in vessels of specific sizes. Participants must consent to the study and can have no more than two target vessels.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- CT-guided PCI
- IVUS-guided PCI
Trial Overview
The P4 study compares CT-guided PCI (a new strategy using computed tomography) against IVUS-guided PCI (an established method using intravascular ultrasound) to see which is better at guiding procedures to open clogged arteries in the heart.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
QAngio CT Research Edition is a software suite providing several functionalities for the analysis of coronary computed tomography angiography (CCTA) scans to extract and present relevant information on the coronary vasculature for further clinical investigation. Also, QAngio CT Research Edition allows to export this information for later viewing during x-ray angiography (XA) procedures to help physicians plan and guide the interventional procedure.
Intravascular ultrasound (IVUS) is an invasive intravascular imaging technique able to visualize the coronary vessel. The use of IVUS-guided PCI has been endorsed an recommended by the European Society of Cardiology. The device is considered part of standard of clinical care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
CoreAalst BV
Lead Sponsor
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