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RECRUITING
NCT05873842

TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

Sponsor: Rede Optimus Hospitalar SA

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2024-07-22

Completion Date

2026-11-01

Last Updated

2025-05-16

Healthy Volunteers

No

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)

Locations (5)

AOU Cardiology Ancona

Ancona, Italy

AULLS3 Cardiology Mestre

Mestre, Italy

AULSS2 Cardiology Treviso

Treviso, Italy

AOUI Cardiology Verona

Verona, Italy

AULLS8 Cardiology Vicenza

Vicenza, Italy