TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
Trial Parameters
Brief Summary
To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.
Eligibility Criteria
Inclusion Criteria: 1. Age \> 18 years 2. Written informed consent 3. Diagnosis of symptomatic severe aortic stenosis 4. Patient undergoing TAVI according to local institutional protocol and following Heart Team discussion. 5. High-quality Contrast-enhanced ECG gated computed tomography (CT) scan of the heart, aorta and low-limb arteries 6. Calcific severe PAD raising concerns within the Heart Team and judged as "arguable" for TF approach following angiography or CT-scan evaluation (hostile femoral access), with a RefD\>/=5 mm and a MLD\>/=3 mm. 7. Hostility score \>/= 23 in at least one segment of the axis under evaluation. Exclusion Criteria: 1. Life expectancy \< 1 year 2. Subject has active infection requiring antibiotic therapy. 3. STS score ≥8% 4. Leriche syndrome or other forms of total occlusion of the aorta or both iliac axes. 5. Planned target limb major amputation (above the ankle). 6. History of prior endovascular or surgical procedure on the index limb within the past 30 d