Precise Procedural and PCI Plan (P4)

Last updated: December 27, 2023
Sponsor: CoreAalst BV
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Cardiac Disease

Hypercholesterolemia

Treatment

IVUS-guided PCI

CT-guided PCI

Clinical Study ID

NCT05253677
CRI-052
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, silentischemia (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 stablecoronary artery disease or stabilized acute coronary syndrome defined as followsunstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMIwithout high-risk features such as recurrence of chest pain, ST-segment depression>1mmin ≥6 leads plus ST-segment elevation in aVR, life-threatening arrhythmias, mechanicalcomplications 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 lesioneven if the side branch is planned to be treated.
  6. Subject must provide written Informed Consent before any study-related procedure.

Exclusion

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 inthe patient presenting with an ACS, or at least 6 months in the patient presentingwith stable CAD, unless the patient is also taking chronic oral anticoagulation inwhich 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 indexprocedure Note: Major surgery is any invasive operative procedure in which anextensive 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 superficialstructures of the body or a manipulative procedure that does not involve a seriousrisk. 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 beadequately pre-medicated.
  16. The subject has received a solid organ transplant that is functioning or is active ona waiting list for any solid organ transplants with expected transplantation within 24months.
  17. The subject receives immunosuppressant therapy or has known immunosuppressive orsevere autoimmune disease that requires chronic immunosuppressive therapy (e.g., humanimmunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids arenot included as immunosuppressant therapy.
  18. The subject has previously received or is scheduled to receive radiotherapy to acoronary 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 orChild-Pugh ≥ Class B.
  21. The subject has a history of bleeding diathesis or coagulopathy or has had asignificant gastro-intestinal or significant urinary bleed within the past six months.The subject has had a cerebrovascular accident or transient ischemic neurologicalattack (TIA) within the past six months, or any prior intracranial bleed, or anypermanent neurologic defect, or any known intracranial pathology (e.g., aneurysm,arteriovenous malformation, etc. The subject has a life expectancy <2 years for anynon-cardiac cause.
  22. Subject is currently participating in another investigational drug or device clinicalstudy.
  23. Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 yearsfollowing index procedure. Female subjects of child-bearing potential must have anegative pregnancy test done within 7 days prior to the index procedure per sitestandard test.
  24. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results.
  25. Unable to provide written informed consent (IC).

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: IVUS-guided PCI
Phase:
Study Start date:
April 01, 2022
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • UZ Brussels

    Jette, Brussels 1090
    Belgium

    Active - Recruiting

  • OLV Hospital

    Aalst, 9300
    Belgium

    Active - Recruiting

  • Hartcentrum ZNA Antwerp

    Antwerp, 2000
    Belgium

    Active - Recruiting

  • Gentofte hospital

    Gentofte, Hellerup 2900
    Denmark

    Active - Recruiting

  • Aarhus Universitetshospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Medical Imaging Centre, Semmelweis University

    Budapest, 1082
    Hungary

    Active - Recruiting

  • Humanitas University

    Milan, 20090
    Italy

    Active - Recruiting

  • Ospedale Galeazzi Sant'Ambrogio

    Milan, 20149
    Italy

    Active - Recruiting

  • Centro Cardiologico Monzino S.P.A.

    Milano,
    Italy

    Active - Recruiting

  • Ospedale Molinette

    Turin, 10126
    Italy

    Site Not Available

  • Royal Bournemouth Hospital

    Bournemouth, Dorset BH7 7DW
    United Kingdom

    Site Not Available

  • University Hospitals Dorset NHS Foundation Trust, Poole Hospital

    Poole, Dorset BH15 2JB
    United Kingdom

    Site Not Available

  • Oxford University Hospital NHS Foundation Trust

    Headington, Oxford OX3 9DU
    United Kingdom

    Site Not Available

  • Golden Jubilee National Hospital

    Clydebank, G81 4DY,
    United Kingdom

    Site Not Available

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' NHS Foundation Trust

    London,
    United Kingdom

    Site Not Available

  • Freeman Hospital

    Newcastle, NE7 7DN
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.