Precise Procedural and PCI Plan (P4)

NCT05253677 | Active Not Recruiting

• 1 other identifier: CRI-052
• Study Type: interventional
• Target: 1,090
• Locations: 8 countries
• Sites: 23

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  12 months follow-up

Secondary Outcomes (23)

• Compare in-hospital resource utilization between CCTA- and IVUS-guided PCI strategies.

  during the intervention

• Compare resource utilization at 12-month follow-up between CCTA- and IVUS-guided PCI strategies

  12 months follow-up

• Compare radiation dose (defined as radiation dose from the invasive procedure) between CCTA- and IVUS- guided PCI strategies.

  periprocedural time frame

• Compare contrast volume (defined as contrast volume used during the invasive procedure) between CCTA- and IVUS- guided PCI strategies.

  periprocedural time frame

• Compare the rate of cardiac death between CCTA- and IVUS-guided PCI strategies.

  12 months follow-up

Study Arms (2)

CT-guided PCI strategy

EXPERIMENTAL

QAngio CT Research Edition is a software suite providing several functionalities for the analysis of coronary computed tomography angiography (CCTA) scans to extract and present relevant information on the coronary vasculature for further clinical investigation. Also, QAngio CT Research Edition allows to export this information for later viewing during x-ray angiography (XA) procedures to help physicians plan and guide the interventional procedure.

Device: CT-guided PCI

intravascular ultrasound (IVUS)-guided PCI strategy

ACTIVE COMPARATOR

Intravascular ultrasound (IVUS) is an invasive intravascular imaging technique able to visualize the coronary vessel. The use of IVUS-guided PCI has been endorsed an recommended by the European Society of Cardiology. The device is considered part of standard of clinical care.

Device: IVUS-guided PCI

Interventions

CT-guided PCI DEVICE

CT-guided PCI with standardized pre-procedural planning and online guidance.

CT-guided PCI strategy

IVUS-guided PCI DEVICE

use of IVUS during PCI procedure (standard of care)

intravascular ultrasound (IVUS)-guided PCI strategy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must be at least 18 years of age and younger than 80 years old.
• Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for elective PCI.
• Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression\>1mm in ≥6 leads plus ST-segment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score\>140.
• All target lesions must be planned for treatment only in vessels with RVD ≥2.5 mm and ≤4.0 mm.
• No more than 2 target vessels are allowed. A bifurcation counts as a single lesion even if the side branch is planned to be treated.
• Subject must provide written Informed Consent before any study-related procedure.

You may not qualify if:

• Age \<18 years or ≥80 years old
• STEMI as clinical presentation.
• Uncontrolled or recurrent ventricular tachycardia.
• Hemodynamic instability.
• Severe renal dysfunction, defined as an eGFR ≤30 mL/min/1.73 m2.
• Atrial fibrillation, flutter, or arrhythmias.
• Previous PCI or CABG.
• The target lesion is in the left main coronary artery
• BMI ≥35 kg/m2.
• Insufficient CT quality assessed by the Core lab.
• Comorbidity with life expectancy ≤ 2 years.
• Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in the patient presenting with an ACS, or at least 6 months in the patient presenting with stable CAD, unless the patient is also taking chronic oral anticoagulation in which case a shorter duration of DAPT may be prescribed per local standard of care.
• Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.
• Prior PCI within the target vessel within 12 months.
• Subject has known hypersensitivity or contraindication to any of the study drugs (including all P2Y12 inhibitors, one or more components of the study devices, including everolimus, zotarolimus, biolimus, sirolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoropolymers, or radiocontrast dye that cannot be adequately pre-medicated.

Sponsors & Collaborators

• CoreAalst BV: lead

Study Sites (23)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

St. Francis Hospital & Heart Center

Roslyn, New York, 11576, United States

Location

UZ Brussels

Jette, Brussels Capital, 1090, Belgium

Location

OLV Hospital

Aalst, 9300, Belgium

Location

Hartcentrum ZNA Antwerp

Antwerp, 2000, Belgium

Location

Gentofte hospital

Gentofte Municipality, Hellerup, 2900, Denmark

Location

Aarhus Universitetshospital

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Centre Hospitalier Universitaire de Lille

Lille, 59037, France

Location

Medical Imaging Centre, Semmelweis University

Budapest, 1082, Hungary

Location

Azienda Ospedaliero Universitaria di Ferrara

Cona, 44124, Italy

Location

Humanitas University

Milan, 20090, Italy

Location

Ospedale Galeazzi Sant'Ambrogio

Milan, 20149, Italy

Location

Centro Cardiologico Monzino S.P.A.

Milan, Italy

Location

Aichi Medical University

Aichi, Japan

Location

University Hospitals Dorset NHS Foundation Trust, Poole Hospital

Poole, Dorset, BH15 2JB, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, G81 4DY,, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, ,SW17 0QT, United Kingdom

Location

Barts Health NHS Trust

London, E1 1FR, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Freeman Hospital

Newcastle, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Carlos Collet Bortone, MD, PhD

  CoreAalst BV

  PRINCIPAL INVESTIGATOR

• Daniele Andreini, MD, PhD

  Milan University, Milan, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: February 24, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): August 4, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); US (3); IT (4); JP (1); HU (1); DK (3); GB (7); BE (3)