Precise Procedural and PCI Plan (P4) (P4)

  • STATUS
    Recruiting
  • End date
    Mar 17, 2029
  • participants needed
    1000
  • sponsor
    CoreAalst BV
Updated on 17 June 2022
angiography
computed tomography angiography
stenosis
chest pain
myocardial infarction
unstable angina
infarct
ischemia
stable angina
coronary ct
acute coronary syndrome
revascularisation

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.

Details
Condition Coronary Artery Disease
Treatment IVUS-guided PCI, CT-guided PCI
Clinical Study IdentifierNCT05253677
SponsorCoreAalst BV
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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
The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum
Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B
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
Subject is currently participating in another investigational drug or device clinical study
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
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
Unable to provide written informed consent (IC)
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