NCT05253677 · ClinicalTrials.gov record · last posted 2026-01-21
Precise Procedural and PCI Plan (P4)
Study acronym: P4
StatusActive, Not Recruiting
PhaseNot applicable
Started2022-04-01
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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.
from the ClinicalTrials.gov record
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.
Amendment record
4 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 4 times since 2022-02-11; most recent amendment 2026-01-19. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
See every version on ClinicalTrials.gov ↗
2026-01-19
Status change Recruiting→Active, Not Recruitingv4
2022-05-30
Status change Not Yet Recruiting→Recruitingv1
| NCT Number |
NCT05253677 |
| Lead Sponsor |
CoreAalst BV
|
| Conditions |
Coronary Artery Disease |
| Enrollment |
1,090 participants |
| Start Date |
2022-04-01 |
| Primary Completion |
2026-08-04 (estimated) |
| Study Completion |
2026-10 (estimated) |
| Updated on ClinicalTrials.gov |
2026-01-21 |