Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
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• Age 18 to 90 years of age, inclusive, at the time of signing the informed consent
• Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's).
• Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure
• Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis.
• Subjects can provide written, informed consent.
Locations
United States
Texas
Baylor Scott and White Heart Hospital
RECRUITING
Plano
Time Frame
Start Date: 2023-03-30
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 50
Related Therapeutic Areas
Sponsors
Leads: Baylor Research Institute
Collaborators: Shockwave Medical, Inc.