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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,090
CT-guided PCI with standardized pre-procedural planning and online guidance.
use of IVUS during PCI procedure (standard of care)
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
...and 13 more locations
rate of MACE between CCTA- and IVUS-guided PCI strategy
Comparison of the rate of the composite of major adverse cardiovascular events, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization between CT- and IVUS-guided PCI strategies at 12-month follow-up
Time frame: 12 months follow-up
Compare in-hospital resource utilization between CCTA- and IVUS-guided PCI strategies.
Compare in-hospital resource utilization (cost from all the procedures during the hospitalisation to discharge in Euros) between CCTA- and IVUS-guided PCI strategies.
Time frame: during the intervention
Compare resource utilization at 12-month follow-up between CCTA- and IVUS-guided PCI strategies
Compare resource utilization (procedural cost and cost from additional interventions in Euros) at 12-month follow-up between CCTA- and IVUS-guided PCI
Time frame: 12 months follow-up
Compare radiation dose (defined as radiation dose from the invasive procedure) between CCTA- and IVUS- guided PCI strategies.
Time frame: periprocedural time frame
Compare contrast volume (defined as contrast volume used during the invasive procedure) between CCTA- and IVUS- guided PCI strategies.
Time frame: periprocedural time frame
Compare the rate of cardiac death between CCTA- and IVUS-guided PCI strategies.
Time frame: 12 months follow-up
Compare the rate of target-vessel myocardial infarction between CCTA- and IVUS-guided PCI strategies.
Time frame: 12 months follow-up
Compare the rate of ischemia-driven target-vessel revascularization between CCTA- and IVUS-guided PCI strategies.
Time frame: 12 months follow-up
Compare the rate of PCI-related MI (type 4a a, 4th Universal Definition of MI) between CCTA- and IVUS-guided PCI strategies
Time frame: during the procedure
Compare the degree of functional revascularization, defined by post-PCI FFR values measured immediately after PCI between CCTA- and IVUS-guided PCI strategies.
Time frame: periprocedural time frame
Compare the degree of functional revascularization, defined by FFRCT Planner, between CCTA- and IVUS-guided PCI strategies.
Time frame: periprocedural time frame
Compare the rate of MACE between patient with complete and incomplete functional revascularization based on the FFRCT Planner, at 12-month follow-up.
Time frame: 12 months follow-up
Compare the rate of MACE between patient with complete and incomplete functional revascularization based on the post-PCI FFR values measured immediately after PCI, at 12-month follow-up.
Time frame: 12 months follow-up
Assess the agreement on post-PCI FFR between the FFRCT Planner and the invasive measurement.
Time frame: periprocedural time frame
Assess the agreement between the FFRCT Planner strategy and the actual treatment performed.
Time frame: periprocedural time frame
Assess the CCTA predictors of stent under expansion.
To assess which characteristics of the plaque, defined by CT, can predict whether the stent is under expansion (by multivariate analysis on the data)
Time frame: periprocedural time frame
To compare angiographic Endpoints (Core Lab assessed QCA): - Final (post-PCI) minimal lumen diameter. - Final (post-PCI) percent diameter stenosis. - Acute lumen gain post-intervention.
Time frame: periprocedural time frame
To compare the maximum device size (stent or post-dilatation balloon)/reference vessel diameter ratio) CCTA- and IVUS-guided PCI strategies.
Time frame: periprocedural time frame
To compare angiographic complications CCTA- and IVUS guided PCI strategies.
Angiographic dissection ≥ NHLBI type B, perforations (Ellis's classification), intra-procedural thrombotic events (including slow-flow, no-reflow, side branch closure, distal embolization, and intra-procedural stent thrombosis, as per the standard angiographic core laboratory definitions
Time frame: periprocedural time frame
To compare procedural time (defined as the time from first to the last angiography) between CCTA- and IVUS-guided PCI strategies.
Time frame: periprocedural time frame
Compare the rate of symptoms-free status assessed by the SAQ-7 between CCTA- and IVUS-guided PCI strategies at 12-months.
Time frame: 12 months follow-up
Compare the change in symptoms assessed by the change of Seattle Angina Questionnaire (SAQ-7) scores between CCTA- and IVUS-guided PCI strategies at 12-months.
Time frame: 12 months follow-up
Compare the change in symptoms assessed by the change of EuroQol 5 dimensions - 5 levels (EQ-5D-5L) scores between CCTA- and IVUS-guided PCI strategies at 12-months.
Time frame: 12 months follow-up
Assess the capacity of the FFRCT Planner (predicted post-PCI FFR) to predict adverse events.
Assess whether the predicted post-PCI FFR value which is calculated by the FFRCT-planner can predict adverse outcomes
Time frame: 12 months follow-up
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