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Precise Procedural and PCI Plan (P4)

Study acronym: P4
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated January 21, 2026 (before its estimated August 4, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 2024 to Aug 4, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 1000 to 1090
    • Study sites: 17 to 23
    v5
  2. Study sites: 15 to 17
    • Primary completion date: Mar 2025 to Dec 2024
    • Study completion date: Mar 2029 to Oct 2026
    v4
  3. Study sites: 14 to 15v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 14
    • Start date changed from estimate of Mar 2022 to Apr 1, 2022
    • Eligibility criteria shortened, about 9 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05253677
Lead Sponsor CoreAalst BV
Conditions
(from sponsor)		 Coronary Artery Disease
Related terms Coronary Artery Disease
Enrollment 1,090 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov