Clinical trial NCT05253677: Precise Procedural and PCI Plan (P4)
Official title: Precise Procedural and PCI Plan (P4) Randomized Clinical Trial Integration of Coronary Computed Tomography Angiography in the Catheterization Laboratory to Plan and Guide Coronary Percutaneous Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: CoreAalst BV
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: rate of MACE between CCTA- and IVUS-guided PCI strategy
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Compare in-hospital resource utilization between CCTA- and IVUS-guided PCI strategies.
timeFrame: during the intervention
measure: Compare resource utilization at 12-month follow-up between CCTA- and IVUS-guided PCI strategies
timeFrame: 12 months follow-up
measure: Compare radiation dose (defined as radiation dose from the invasive procedure) between CCTA- and IVUS- guided PCI strategies.
timeFrame: periprocedural time frame
measure: Compare contrast volume (defined as contrast volume used during the invasive procedure) between CCTA- and IVUS- guided PCI strategies.
timeFrame: periprocedural time frame
measure: Compare the rate of cardiac death between CCTA- and IVUS-guided PCI strategies.
timeFrame: 12 months follow-up
measure: Compare the rate of target-vessel myocardial infarction between CCTA- and IVUS-guided PCI strategies.
timeFrame: 12 months follow-up
measure: Compare the rate of ischemia-driven target-vessel revascularization between CCTA- and IVUS-guided PCI strategies.
timeFrame: 12 months follow-up
measure: Compare the rate of PCI-related MI (type 4a a, 4th Universal Definition of MI) between CCTA- and IVUS-guided PCI strategies
timeFrame: during the procedure
measure: Compare the degree of functional revascularization, defined by post-PCI FFR values measured immediately after PCI between CCTA- and IVUS-guided PCI strategies.
timeFrame: periprocedural time frame
measure: Compare the degree of functional revascularization, defined by FFRCT Planner, between CCTA- and IVUS-guided PCI strategies.
timeFrame: periprocedural time frame
measure: Compare the rate of MACE between patient with complete and incomplete functional revascularization based on the FFRCT Planner, at 12-month follow-up.
timeFrame: 12 months follow-up
measure: 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.
timeFrame: 12 months follow-up
measure: Assess the agreement on post-PCI FFR between the FFRCT Planner and the invasive measurement.
timeFrame: periprocedural time frame
measure: Assess the agreement between the FFRCT Planner strategy and the actual treatment performed.
timeFrame: periprocedural time frame
measure: Assess the CCTA predictors of stent under expansion.
timeFrame: periprocedural time frame
measure: 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.
timeFrame: periprocedural time frame
measure: To compare the maximum device size (stent or post-dilatation balloon)/reference vessel diameter ratio) CCTA- and IVUS-guided PCI strategies.
timeFrame: periprocedural time frame
measure: To compare angiographic complications CCTA- and IVUS guided PCI strategies.
timeFrame: periprocedural time frame
measure: To compare procedural time (defined as the time from first to the last angiography) between CCTA- and IVUS-guided PCI strategies.
timeFrame: periprocedural time frame
measure: Compare the rate of symptoms-free status assessed by the SAQ-7 between CCTA- and IVUS-guided PCI strategies at 12-months.
timeFrame: 12 months follow-up
measure: 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.
timeFrame: 12 months follow-up
measure: 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.
timeFrame: 12 months follow-up
measure: Assess the capacity of the FFRCT Planner (predicted post-PCI FFR) to predict adverse events.
timeFrame: 12 months follow-up
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussels
state: Brussels
city: Aalst
country: Belgium
facility: OLV Hospital
city: Antwerp
country: Belgium
facility: Hartcentrum ZNA Antwerp
city: Gentofte
country: Denmark
facility: Gentofte hospital
state: Hellerup
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Budapest
country: Hungary
facility: Medical Imaging Centre, Semmelweis University
city: Milano
country: Italy
facility: Centro Cardiologico Monzino S.P.A.
city: Milan
country: Italy
facility: Humanitas University
city: Milan
country: Italy
facility: Ospedale Galeazzi Sant'Ambrogio
city: Turin
country: Italy
facility: Ospedale Molinette
city: Poole
country: United Kingdom
facility: University Hospitals Dorset NHS Foundation Trust, Poole Hospital
state: Dorset
city: Headington
country: United Kingdom
facility: Oxford University Hospital NHS Foundation Trust
state: Oxford
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: CoreAalst BV
name: Carlos Collet Bortone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Milan University, Milan, Italy
name: Daniele Andreini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: