Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255678
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-01-16
Brief Title:
Angio-based Final Functional Effect of PCI
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official Title:
Angio-based Final Functional Effect of PCI AFFE PCI a Prospective Multi-center Study of Post-PCI vFFR Impact on Clinical Outcomes and Residual Angina
Status:
RECRUITING
Status Verified Date:
2024-02
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:
AFFE-PCI
Brief Summary:
Fractional flow reserve FFR has revolutionized the diagnosis and treatment of coronary artery disease CAD and more recently post percutaneous coronary intervention post-PCI FFR has emerged as an independent predictor of cardiovascular events enabling the identification of cases requiring additional optimization of the implanted stent Modern technologies allow less invasive alternatives to traditional FFR measurement - angiography-based vessel fractional flow reserve vFFR and derivative ΔvFFR which is calculated by a difference between the post-PCI vFFR and pre-PCI vFFR In large clinical studies the good accuracy between vFFR and FFR - measured before and after PCI - has been confirmed However insufficient data is available about the value of post-vFFR and ΔvFFR as prognostic values and indicators of patient health
This is a prospective multicenter register study analyzing the association between the value of ΔvFFR vFFR after PCI and adverse clinical outcomes residual angina and quality of life using the validated Seattle Angina Questionnaire SAQ and EuroQol 5-level 5-dimensional questionnaire EQ-5D-5L Patients undergoing PCI for chronic coronary syndromes CCS non-ST-segment elevation acute coronary syndromes NST-ACS or ST-Segment Elevation Myocardial Infarction STEMI will be enrolled in this study
This is a prospective multicenter register study analyzing the association between the value of ΔvFFR vFFR after PCI and adverse clinical outcomes residual angina and quality of life using the validated Seattle Angina Questionnaire SAQ and EuroQol 5-level 5-dimensional questionnaire EQ-5D-5L Patients undergoing PCI for chronic coronary syndromes CCS non-ST-segment elevation acute coronary syndromes NST-ACS or ST-Segment Elevation Myocardial Infarction STEMI will be enrolled in this study
Detailed Description:
The primary goal of this prospective multicenter register study is to evaluate the association between the value of vFFR after PCI and adverse clinical outcomes residual angina and quality of life using the validated Seattle Angina Questionnaire SAQ and EuroQol 5-level 5-dimensional questionnaire EQ-5D-5L at 6 and 24 months following PCI The primary composite endpoint is defined as a major adverse cardiovascular event MACE including all-cause death target-vessel myocardial infarction TVMI and target vessel revascularization TVR at 6 12 and 24-month follow-ups Patients undergoing PCI for chronic coronary syndromes CCS non-ST-segment elevation acute coronary syndromes NST-ACS or or ST-Segment Elevation Myocardial Infarction STEMI will be enrolled in this study The analyses of the primary endpoint will be stratified according to the following subgroups
Diabetesnon-diabetes
Glomerular filtration rate GFR60GFR60 mlmin173m2
Focaldiffuse atherosclerosis
Multivesselsingle-vessel disease
CCSNST-ACSSTEMI
CCSACS
The patients coronary angiograms will be analyzed using a CAAS workstation Pie Medical Imaging Maastricht the Netherlands enrolled at the Invasive Cardiology Unit of the 1st Department of Cardiology Medical University of Warsaw Poland and other centers in Poland
Diabetesnon-diabetes
Glomerular filtration rate GFR60GFR60 mlmin173m2
Focaldiffuse atherosclerosis
Multivesselsingle-vessel disease
CCSNST-ACSSTEMI
CCSACS
The patients coronary angiograms will be analyzed using a CAAS workstation Pie Medical Imaging Maastricht the Netherlands enrolled at the Invasive Cardiology Unit of the 1st Department of Cardiology Medical University of Warsaw Poland and other centers in Poland
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