Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04976062
Status:
RECRUITING
Last Update Posted:
2022-11-04
First Post:
2021-07-04
Brief Title:
NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation the IMPACTavi Trial
Status:
RECRUITING
Status Verified Date:
2022-11
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:
IMPACTavi
Brief Summary:
The aim of the IMPACTavi prospective cohort study is to test feasibility and safety of clinically indicated intravascular coronary imaging with NIRS-IVUS in addition to routine coronary angiography in patients scheduled for TAVI to improve assessment of CAD severity in this challenging group of patients
Detailed Description:
Concomitant coronary artery disease CAD is frequent in patients referred for transcatheter aortic valve replacement TAVI and there is evidence for a subsequent prognostic impairment Percutaneous coronary intervention PCI is believed to improve prognosis in selected cases which is why current guidelines recommend PCI to be considered in case of coronary artery diameter stenosis 70 in proximal segments Beyond those cases selection is hampered by inherent shortcoming of the assessment of CAD severity by angiography alone as well as clinical and complex hemodynamic interactions between both pathologies In patients with CAD alone the FDA-cleared near-infrared spectroscopy and intravascular imaging NIRS-IVUS dual imaging catheter Indfraredx Inc Bedford USA has proven the ability to reliably measure lipid plaque burden as well as to identify patients and plaques at increased risk for future adverse cardiovascular events NIRS-IVUS imaging offers the unique possibility to improve angiographic CAD severity assessment in patients referred for TAVI avoiding the influence of hemodynamic interactions and pathophysiological overlap between CAD and severe AS
The IMPACTavi trial is designed as a prospective non-randomized cohort study to investigate whether NIRS-IVUS-derived lesion characteristics will allow identification of patients likely to suffer adverse clinical events during clinical follow-up after TAVI Patients with severe aortic stenosis will be qualified for enrollment if routine coronary angiography during diagnostic workup before TAVI shows evidence of coronary artery disease with at least one native vessel without prior stent implantation and at least one lesion requiring NIRS-IVUS imaging for clinical indications and if at 30mm of total NIRS-IVUS pullback length in sufficient quality for offline analysis have been obtained Clinical indication technique and timing of PCI and TAVI will be at the discretion of the interdisciplinary heart-team The primary and secondary endpoints will be assessed during clinical follow-up out to 24 months Findings from NIRS-IVUS imaging will be analyzed on a patient- and lesion-level in order to evaluate correlations of high- vs low-risk lesion characteristics to the incidence of patient- and lesion-level MACE
The IMPACTavi trial is designed as a prospective non-randomized cohort study to investigate whether NIRS-IVUS-derived lesion characteristics will allow identification of patients likely to suffer adverse clinical events during clinical follow-up after TAVI Patients with severe aortic stenosis will be qualified for enrollment if routine coronary angiography during diagnostic workup before TAVI shows evidence of coronary artery disease with at least one native vessel without prior stent implantation and at least one lesion requiring NIRS-IVUS imaging for clinical indications and if at 30mm of total NIRS-IVUS pullback length in sufficient quality for offline analysis have been obtained Clinical indication technique and timing of PCI and TAVI will be at the discretion of the interdisciplinary heart-team The primary and secondary endpoints will be assessed during clinical follow-up out to 24 months Findings from NIRS-IVUS imaging will be analyzed on a patient- and lesion-level in order to evaluate correlations of high- vs low-risk lesion characteristics to the incidence of patient- and lesion-level MACE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None