Clinical Trial

TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI

Study acronym: TRAFIC-PTA
Recruiting
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-05-15; most recent amendment 2025-05-13.
Status change: Not Yet Recruiting → Recruiting 2025-05-13
Trial Details
NCT Number NCT05873842
Lead Sponsor Rede Optimus Hospitalar SA
Conditions Trans-femoral TAVI With Calcified Ilio-femoral Arteries
Enrollment 50 participants
Start Date 2024-07-22
Primary Completion 2026-11-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-16