IVUS Analysis for Coronary Obstruction in TAVI (ICARO)
Coronary Artery Occlusion
About this trial
This is an interventional prevention trial for Coronary Artery Occlusion
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Written informed consent
- Diagnosis of symptomatic severe aortic stenosis, or clinically relevant degeneration of previously implanted surgical aortic valve bioprosthesis
- Patient undergoing TAVI according to local institutional protocol and following Heart Team discussion.
- High-quality ECG gated computed tomography (CT) scan of the heart and aorta
- Presence of 2 or more of the following risk factors for CAO (high-risk):
6a. TAVI in native valves: height of the coronary ostium (<9 mm), sinuses of Valsalva width <30 mm, leaflet tips extending above the coronary ostia or the sino-tubular junction.
6b. VIV-TAVI (patients undergoing BASILICA as first prevention strategy are also included): surgical bioprosthesis type: with supra-annular position, high leaflet profile, externally mounted leaflets stented valve, stentless valves, and bulky leaflets, low-lying coronary ostia (< 9 mm from the ostia to the sewing ring), narrow sinuses of Valsalva (<30 mm by width for Valsalva sinuses), virtual THV-coronary (VTC) distance <4 mm, virtual THV-STJ (VT-STJ) distance < 2.5-3.5 mm: to be considered in cases where VTC >4mm but the leaflet extends above or very close (up to 2mm below) to the STJ plane.
Exclusion Criteria:
- Age < 18 years
- Pregnancy
- Absence of informed consent
- Angiographic or functional critical stenosis of the at-risk coronary artery (%DS > 70 for right coronary artery, > 50 for left main, or positive functional assessment), requiring revascularization regardless the risk of CAO.
- Signs or symptoms of acute (unstable) myocardial ischemia
- Reduced survival expectancy due to severe co-morbidities (<1 year)
Sites / Locations
- AOUI VeronaRecruiting
Arms of the Study
Arm 1
Experimental
IVUS-guided