RecruitingNCT05873842

TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

Sponsor

Rede Optimus Hospitalar SA

Enrollment

50 participants

Start Date

Jul 22, 2024

Study Type

OBSERVATIONAL

Conditions

Trans-femoral TAVI With Calcified Ilio-femoral Arteries

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Trans-femoral TAVI for people with trans-femoral tavi with calcified ilio-femoral arteries. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETrans-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

View Full Details on ClinicalTrials.gov

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NCT05873842