NCT05862558

Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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)

Detailed description

The goal of this post-market, prospective, observational single-arm cohort study is 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). This is a study of patients referred to BSW The Heart Hospital, Plano for evaluation of critical aortic stenosis. Those planned to undergo TAVR, have prohibitive iliofemoral disease, and otherwise considered for alternative access, will be considered for the study. The medical devices being used are in the post-market stage as it is being used in accordance with its approved labeling, treating iliofemoral disease. Study data will be recorded prospectively on dedicated Data Collection Forms and stored locally in a secure format. De-identified data will be uploaded for statistical analysis. IRB approval for the study will be obtained.

Conditions

• Iliac Disease
• Aortic Valve Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-30
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-05-17
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States