CT vs IVUS-Guided PCI for Coronary Artery Disease

(P4 Trial)

Not currently recruiting at 27 trial locations
SP
AR
Overseen ByAnne-Sophie Rowies, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: CoreAalst BV
Must be taking: DAPT
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to guide a procedure called PCI, which opens blocked heart arteries for those with coronary artery disease. One method uses a CT scan, a detailed imaging technique, while the other uses IVUS, an imaging tool inside the blood vessels. The trial aims to determine which method results in better patient outcomes. Individuals with stable heart conditions, such as angina or certain heart attacks, who require PCI may be suitable candidates for this trial. As an unphased study, it offers participants the chance to contribute to innovative research that could enhance future heart treatments.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, you must be able to take dual antiplatelet therapy (DAPT) for a certain period unless you are on chronic oral anticoagulation. It's best to discuss your specific medications with the trial team.

What prior data suggests that these imaging strategies are safe for guiding PCI?

Research has shown that using CT scans to guide PCI (a heart procedure) is generally well-tolerated. One study found that coronary CT angiography (CCTA) aids doctors in planning and decision-making during the procedure. This method is considered safe, with few side effects reported.

In comparison, using ultrasound (IVUS) to guide PCI is a common practice recommended by the European Society of Cardiology. It is widely used because it provides clear images of the heart's blood vessels, and patients usually tolerate this procedure well.

Both CT-guided and IVUS-guided PCI methods are considered safe, with minimal risks. However, like any medical procedure, some side effects may occur. Discuss any concerns with your doctor.1234

Why are researchers excited about this trial?

Researchers are excited about the CT-guided PCI strategy for coronary artery disease because it offers a non-invasive approach to planning and guiding procedures. Unlike the standard IVUS-guided PCI, which involves inserting a device into the artery, the CT-guided method uses advanced software to analyze CT scans and assist doctors in visualizing and planning the intervention without direct vessel entry. This approach could potentially reduce procedural risks and make the treatment more comfortable for patients, while still providing detailed insights into the coronary arteries.

What evidence suggests that this trial's imaging strategies could be effective for guiding PCI in coronary artery disease?

This trial will compare CT-guided PCI with IVUS-guided PCI for coronary artery disease. Research has shown that coronary CT angiography (CCTA), used in the CT-guided PCI arm of this trial, serves as a key tool for planning procedures to open blocked heart arteries, known as percutaneous coronary intervention (PCI). Studies indicate that CCTA can improve outcomes for patients suspected of having coronary artery disease by helping doctors plan more effective treatments. Specifically, trials have shown positive results when using CCTA for patients with acute coronary syndrome (ACS), highlighting its usefulness in guiding PCI. This technology provides detailed images of the heart's blood vessels, aiding in better treatment decisions. Overall, CCTA is increasingly recognized as a valuable method in planning PCI.3567

Who Is on the Research Team?

CC

Carlos Collet Bortone, MD, PhD

Principal Investigator

CoreAalst BV

DA

Daniele Andreini, MD, PhD

Principal Investigator

Milan University, Milan, Italy

Are You a Good Fit for This Trial?

This trial is for patients with myocardial ischemia or stable coronary artery disease suitable for elective PCI. It includes those with unstable angina, NSTEMI without high-risk features, and lesions in vessels of specific sizes. Participants must consent to the study and can have no more than two target vessels.

Inclusion Criteria

I have heart issues that can be treated with a planned heart procedure.
Subject must provide written Informed Consent before any study-related procedure.
I have stable heart disease or recently stabilized heart condition without high-risk complications.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either CT-guided or IVUS-guided PCI procedures following randomization

Periprocedural time frame
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 30 days, 12 months, and yearly until 5 years

5 years
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • CT-guided PCI
  • IVUS-guided PCI

Trial Overview

The P4 study compares CT-guided PCI (a new strategy using computed tomography) against IVUS-guided PCI (an established method using intravascular ultrasound) to see which is better at guiding procedures to open clogged arteries in the heart.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: CT-guided PCI strategyExperimental Treatment1 Intervention
Group II: intravascular ultrasound (IVUS)-guided PCI strategyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CoreAalst BV

Lead Sponsor

Trials
9
Recruited
6,300+

Citations

Long-term Health Outcomes and Cost-Effectiveness of ...

Randomized trials have shown favorable clinical outcomes for coronary CT angiography (CTA) in patients with suspected acute coronary syndrome (ACS).

With CCTA Poised to Transform PCI Planning, SCAI/SCCT ...

Unlike traditional diagnostic coronary CT, which may be interpreted by imagers alone, CT-guided PCI requires collaboration between specialists ...

Coronary Computed Tomography Angiography to Guide ...

Coronary computed tomography angiography (CCTA) has emerged as an important tool for planning percutaneous coronary intervention (PCI).

Clinical Outcomes Based on Coronary Computed ...

Of 745 patients, 211 (28.3%) underwent ICA, and 93 (12.5%) patients were originally referred for revascularization; 11 patients received ...

Coronary Computed Tomography Angiography to Guide ...

The goal of this document is to provide a state-of-the-art overview of CCTA-guided PCI focused on practical applications and key coronary lesion subsets, define ...

CAD-RADS™ 2.0 - 2022 Coronary Artery Disease ...

The goal of this updated 2022 CAD-RADS 2.0 is to improve the initial reporting system for CCTA by considering new technical developments in ...

Study Details | NCT07286578 | A Prospective, Multicenter, ...

The trial aims to determine whether leveraging non-invasive CT-based calcium assessment can enhance procedural efficiency and stent results while maintaining ...