TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Rede Optimus Hospitalar SA trials in Italy
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