P4-study v1.0 - UK
Research type
Research Study
Full title
Precise Procedural and PCI Plan (P4) Randomized Clinical Trial
IRAS ID
310512
Contact name
Alan Bagnall
Contact email
Sponsor organisation
CoreAalst BV
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 2 months, 31 days
Research summary
Coronary CT angiography (CCTA) has emerged as the preferred method for non-invasive assessment of coronary artery disease (CAD). However, its usefulness beyond the diagnostic phase remains to be determined. The availability of CCTA before the invasive procedure allows stratifying case complexity and help to organize Cath Lab’s logistic and personnel better, and improve workflow, efficiency, and resource utilization. The integration of CCTA in the catheterization laboratory could guide the selection of the revascularization strategy and improve the procedure's safety in terms of radiation dose and contrast volume. The P4 study is an investigator-initiated, multicenter, randomized study with a non-inferiority design of patients with an indication for percutaneous coronary intervention. It aims at comparing clinical outcomes after CCTA- versus IVUS-guided PCI strategies at 1-year follow-up and optional yearly until 5 years. Patients with stable coronary artery disease or stabilized non-ST elevation acute coronary syndromes (ACS), a significant epicardial lesion (defined as a lesion with ≥70% stenosis by CCTA and FFRCT≤0.80) with a clinical indication for revascularization will be deemed eligible for the study. After the informed consent is signed, patients will be randomized either to CCTA- or IVUS-guided PCI strategies. In case of a CCTA-guided PCI, the core lab will provide the site with the “CT planning package”, that includes information derived from CCTA analysis, the online guidance, that allows real-time integration of a 3D model of the coronary tree in the cath lab, and the FFRCT Planner, a tool able to predict the hemodynamic effect of virtual stenting. For patients randomized to IVUS-guided PCI, IVUS will be performed pre and post-PCI according to standard clinical care. Approximately 1000 patients will be enrolled in 13 European clinical sites having the latest generation of CT scanners.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
23/WM/0063
Date of REC Opinion
11 May 2023
REC opinion
Further Information Favourable Opinion