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Precise Procedural and PCI Plan (P4)
NCT05253677 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DEVICE CT-guided PCI
- DEVICE IVUS-guided PCI
Study Locations (20)
Other
- OLV Hospital — Aalst
- Hartcentrum ZNA Antwerp — Antwerp
- Aarhus Universitetshospital — Aarhus
- Rigshospitalet — Copenhagen
- Centre Hospitalier Universitaire de Lille — Lille
- Medical Imaging Centre, Semmelweis University — Budapest
- Azienda Ospedaliero Universitaria di Ferrara — Cona
- Humanitas University — Milan
- Ospedale Galeazzi Sant'Ambrogio — Milan
- Centro Cardiologico Monzino S.P.A. — Milan
- Aichi Medical University — Aichi
- Golden Jubilee National Hospital — Clydebank
- Liverpool Heart and Chest Hospital — Liverpool
- St George's University Hospitals NHS Foundation Trust — London
California
- Cedars-Sinai Medical Center — Los Angeles
Minnesota
- Minneapolis Heart Institute Foundation — Minneapolis
New York
- St. Francis Hospital & Heart Center — Roslyn
Brussels Capital
- UZ Brussels — Jette
Hellerup
- Gentofte hospital — Gentofte Municipality
Dorset
- University Hospitals Dorset NHS Foundation Trust, Poole Hospital — Poole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,090 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2026-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05253677
The ClinicalTrials.gov registry entry for NCT05253677 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,090 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CoreAalst, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions — of which CT-guided PCI is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05253677 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05253677 about?
NCT05253677 is a clinical study titled "Precise Procedural and PCI Plan (P4)". 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 ...
What is the current status of trial NCT05253677?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,090 participants. The study started on 2022-04-01. Estimated completion is 2026-10.
What conditions does trial NCT05253677 study?
This clinical trial studies the following conditions: Coronary Artery Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05253677?
The interventions under investigation include: CT-guided PCI (DEVICE), IVUS-guided PCI (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05253677?
This trial is sponsored by CoreAalst, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05253677 being conducted?
This trial has 20 study locations across California, Minnesota, New York, Brussels Capital, Hellerup. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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