Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05253677
NA

Precise Procedural and PCI Plan (P4)

Sponsor: CoreAalst BV

View on ClinicalTrials.gov

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

Interventions

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)

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