Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05253677
Status:
RECRUITING
Last Update Posted:
2023-12-28
First Post:
2021-12-06
Brief Title:
Precise Procedural and PCI Plan P4
Sponsor:
CoreAalst BV
Organization:
CoreAalst BV
Study Overview
Official Title:
Precise Procedural and PCI Plan P4 Randomized Clinical Trial Integration of Coronary Computed Tomography Angiography in the Catheterization Laboratory to Plan and Guide Coronary Percutaneous Procedures
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P4
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None