Ignite Creation Date:
2024-05-06 @ 5:48 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05437900
Status:
RECRUITING
Last Update Posted:
2023-08-14
First Post:
2022-06-02
Brief Title:
INSIGHTFUL-FFR Clinical Trial
Sponsor:
CoreAalst BV
Organization:
CoreAalst BV
Study Overview
Official Title:
Pressure Microcatheter vs Pressure Wire for Clinical Decision Making and PCI Optimization
Status:
RECRUITING
Status Verified Date:
2023-08
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:
None
Brief Summary:
Recently a new device for measuring physiological lesion severity the pressure microcatheter was introduced The pressure microcatheter provides similar information to the conventional measurement technique but differs as it is easily advanced on a customary coronary wire and simplifies pullback maneuvers The pressure microcatheter has been shown to provide comparable FFR results to pressure wires
Insightful-FFR is an investigator-driven multicenter randomized open-label and prospective trial of patients with stable coronary artery disease or stabilised non-ST elevation acute coronary syndrome ACS with epicardial stenosis considered for PCI aiming at comparing clinical outcomes between pressure microcatheter and pressure wire-guided strategies The study hypothesis states that the use of a Pressure Microcatheter for clinical decision making would be non-inferior to pressure wire-based strategy
After determining the presence of a coronary artery disease stabilized acute coronary syndrome patients will be randomized to use a pressure microcatheter investigational device or a pressure wire comparator to guide and optimize percutaneous coronary intervention PCI Patients will be followed up in hospital at 12 months and yearly until five years
Insightful-FFR is an investigator-driven multicenter randomized open-label and prospective trial of patients with stable coronary artery disease or stabilised non-ST elevation acute coronary syndrome ACS with epicardial stenosis considered for PCI aiming at comparing clinical outcomes between pressure microcatheter and pressure wire-guided strategies The study hypothesis states that the use of a Pressure Microcatheter for clinical decision making would be non-inferior to pressure wire-based strategy
After determining the presence of a coronary artery disease stabilized acute coronary syndrome patients will be randomized to use a pressure microcatheter investigational device or a pressure wire comparator to guide and optimize percutaneous coronary intervention PCI Patients will be followed up in hospital at 12 months and yearly until five years
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