Precise Procedural and PCI Plan (P4)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CT-guided PCI strategy

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.

Group Type EXPERIMENTAL

CT-guided PCI

Intervention Type DEVICE

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

intravascular ultrasound (IVUS)-guided PCI strategy

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.

Group Type ACTIVE_COMPARATOR

IVUS-guided PCI

Intervention Type DEVICE

use of IVUS during PCI procedure (standard of care)

Interventions

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CT-guided PCI

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

Intervention Type DEVICE

IVUS-guided PCI

use of IVUS during PCI procedure (standard of care)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The subject must be at least 18 years of age and younger than 80 years old.
2. 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.
3. 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.
4. All target lesions must be planned for treatment only in vessels with RVD ≥2.5 mm and ≤4.0 mm.
5. 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.
6. Subject must provide written Informed Consent before any study-related procedure.

Exclusion Criteria

1. Age \<18 years or ≥80 years old
2. STEMI as clinical presentation.
3. Uncontrolled or recurrent ventricular tachycardia.
4. Hemodynamic instability.
5. Severe renal dysfunction, defined as an eGFR ≤30 mL/min/1.73 m2.
6. Atrial fibrillation, flutter, or arrhythmias.
7. Previous PCI or CABG.
8. The target lesion is in the left main coronary artery
9. BMI ≥35 kg/m2.
10. Insufficient CT quality assessed by the Core lab.
11. Comorbidity with life expectancy ≤ 2 years.
12. 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.
13. 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.
14. Prior PCI within the target vessel within 12 months.
15. 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.
16. The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
17. The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
18. The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.
19. Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.
20. The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
21. The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy \<2 years for any non-cardiac cause.
22. Subject is currently participating in another investigational drug or device clinical study.
23. Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
24. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
25. Unable to provide written informed consent (IC).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Collet Bortone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CoreAalst BV

Daniele Andreini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Milan University, Milan, Italy

Locations

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UZ Brussels

Jette, Brussels Capital, Belgium

Site Status RECRUITING

OLV Hospital

Aalst, , Belgium

Site Status RECRUITING

Hartcentrum ZNA Antwerp

Antwerp, , Belgium

Site Status RECRUITING

Gentofte hospital

Gentofte Municipality, Hellerup, Denmark

Site Status RECRUITING

Aarhus Universitetshospital

Aarhus, , Denmark

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Medical Imaging Centre, Semmelweis University

Budapest, , Hungary

Site Status RECRUITING

Humanitas University

Milan, , Italy

Site Status RECRUITING

Ospedale Galeazzi Sant'Ambrogio

Milan, , Italy

Site Status RECRUITING

Centro Cardiologico Monzino S.P.A.

Milan, , Italy

Site Status RECRUITING