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RECRUITING
NCT05862558

Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Sponsor: Baylor Research Institute

View on ClinicalTrials.gov

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

Interventions

DEVICE

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