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Precise Procedural and PCI Plan (P4)
Sponsor: CoreAalst BV
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1090
Start Date
2022-04-01
Completion Date
2026-10
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
CT-guided PCI
CT-guided PCI with standardized pre-procedural planning and online guidance.
IVUS-guided PCI
use of IVUS during PCI procedure (standard of care)
Locations (23)
Cedars-Sinai Medical Center
Los Angeles, California, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
St. Francis Hospital & Heart Center
Roslyn, New York, United States
UZ Brussels
Jette, Brussels Capital, Belgium
OLV Hospital
Aalst, Belgium
Hartcentrum ZNA Antwerp
Antwerp, Belgium
Gentofte hospital
Gentofte Municipality, Hellerup, Denmark
Aarhus Universitetshospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Centre Hospitalier Universitaire de Lille
Lille, France
Medical Imaging Centre, Semmelweis University
Budapest, Hungary
Azienda Ospedaliero Universitaria di Ferrara
Cona, Italy
Humanitas University
Milan, Italy
Ospedale Galeazzi Sant'Ambrogio
Milan, Italy
Centro Cardiologico Monzino S.P.A.
Milan, Italy
Aichi Medical University
Aichi, Japan
University Hospitals Dorset NHS Foundation Trust, Poole Hospital
Poole, Dorset, United Kingdom
Golden Jubilee National Hospital
Clydebank, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Freeman Hospital
Newcastle, United Kingdom