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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Sponsor: Baylor Research Institute
Summary
To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access TAVR. (e.g. trans-carotid)
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2023-03-30
Completion Date
2026-06-01
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
Shockwave Balloon
Intravascular lithotripsy (IVL) performed with the Shockwave balloon (Shockwave Medical Inc) enables treatment of calcified stenosis of the peripheral arteries by using sonic pressure waves to selectively disrupt superficial and deep calcium without impacting healthy tissue
Locations (1)
Baylor Scott and White Heart Hospital
Plano, Texas, United States