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
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.
• The subject must be at least 18 years of age and younger than 80 years old.
• 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.
• 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.
• All target lesions must be planned for treatment only in vessels with RVD ≥2.5 mm and ≤4.0 mm.
• 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.
• Subject must provide written Informed Consent before any study-related procedure.