TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
NCT05873842 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50
Last updated 2025-05-16
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.
Conditions
- Trans-femoral TAVI With Calcified Ilio-femoral Arteries
Interventions
- DEVICE
-
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)
Sponsors & Collaborators
-
Rede Optimus Hospitalar SA
lead NETWORK
Principal Investigators
-
Flavio Ribichini, MD, PhD · AOUI, Verona
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-22
- Primary Completion
- 2026-11-01
- Completion
- 2026-11-01
Countries
- Italy
Study Locations
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