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Precise Procedural and PCI Plan (P4)

NCT05253677 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1090

Last updated 2026-01-21

No results posted yet for this 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.

Conditions

Interventions

DEVICE

CT-guided PCI

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

DEVICE

IVUS-guided PCI

use of IVUS during PCI procedure (standard of care)

Sponsors & Collaborators

  • CoreAalst BV

    lead INDUSTRY

Principal Investigators

  • Carlos Collet Bortone, MD, PhD · CoreAalst BV

  • Daniele Andreini, MD, PhD · Milan University, Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2026-08-04
Completion
2026-10-31

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Hungary
  • Italy
  • Japan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05253677 on ClinicalTrials.gov