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NCT05253677 · ClinicalTrials.gov registry record · NA
Precise Procedural and PCI Plan (P4)
A NA study of Coronary Artery Disease, sponsored by CoreAalst.
- Active
- Registry status
- NA
- Development phase
- 1,090
- Enrollment target
- 20
- Study locations
NCT05253677 is a NA study of Coronary Artery Disease that is active but no longer recruiting, run by CoreAalst. The registered enrollment target is 1,090 participants, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT05253677, a NA study of Coronary Artery Disease, is active but no longer recruiting, sponsored by CoreAalst.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,090 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 1,090 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (15% lower). The listed sponsor is CoreAalst, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT05253677 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, California, Minnesota.
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.
What interventions are being tested in trial NCT05253677?
The interventions under investigation include: CT-guided PCI (DEVICE), IVUS-guided PCI (DEVICE).
Who is sponsoring clinical trial NCT05253677?
This trial is sponsored by CoreAalst, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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Related
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