NCT05253677

Precise Procedural and PCI Plan (P4)

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,090 (estimated)
• Sponsor: CoreAalst BV · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	CT-guided PCI	CT-guided PCI with standardized pre-procedural planning and online guidance.
DEVICE	IVUS-guided PCI	use of IVUS during PCI procedure (standard of care)

Timeline

• Start date: 2022-04-01
• Primary completion: 2026-08-04
• Completion: 2026-10-01
• First posted: 2022-02-24
• Last updated: 2026-01-21

Locations

23 sites across 8 countries: United States, Belgium, Denmark, France, Hungary, Italy, Japan, United Kingdom