Ireland
--:--IST
Recruiting Observational

TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

NCT05873842 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-07-22
Last updated
2025-05-16

Condition(s) studied

Trans-femoral TAVI With Calcified Ilio-femoral Arteries

Investigational drug(s) / intervention(s)

Trans-femoral TAVI

Trans-femoral TAVI: Trans-femoral TAVI (Trans-catheter Aortic Valve Implantation) with calcified ilio-femoral arteries via PTA (Percutaneous transluminal angioplasty ) or IVL (Intra-vascular Lithotripsy)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 days or planned within 30 days of the index procedure. 7. Subject in whom antiplatelet or anticoagulant therapy is contraindicated. 8. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated. 9. Subject has known allergy to urethane, nylon, or silicone. 10. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. 11. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment. 12. The use of specialty balloons, re-entry or atherectomy devices

Primary outcome measure(s)

  • Feasibility and safety on the trans-femoral (TF) approach — Index procedure - 1 Month
    Comparison of feasibility and safety on the TF approach as the composite of: * Valve implant unsuccess due to difficulties in advancing through the ilio-femoral vascular axe * Absence of cross over from PTA to IVL or vice-versa * Absence of severe vascular and bleeding complications at discharge and at 1 month follow up visit, as defined by VARC-3

Trial sites (5)

FacilityCityRegionStatus
AOU Cardiology Ancona Ancona Italy Recruiting
AULLS3 Cardiology Mestre Mestre Italy Recruiting
AULSS2 Cardiology Treviso Treviso Italy Active Not Recruiting
AOUI Cardiology Verona Verona Italy Recruiting
AULLS8 Cardiology Vicenza Vicenza Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05873842 on ClinicalTrials.gov ↗ ← All trials in Italy