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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: Active NA study of Coronary Artery Disease, sponsored by CoreAalst.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Comparison of the rate of the composite of major adverse cardiovascular events, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization between CT- and IVUS-guided PCI strategies at 12-month follow-up
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 |
What the registry record for NCT05253677 still lists
NCT05253677 is an interventional study that assigns participants to a tested intervention. Its 1,090 participants enrollment target places it among the larger protocols in the corpus, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (15% lower).
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
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Where NCT05253677's enrollment target sits among peer trials
1,090 43rd of 219 higher than 177 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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