Actively Recruiting
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Led by Baylor Research Institute · Updated on 2026-01-13
50
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
B
Baylor Research Institute
Lead Sponsor
S
Shockwave Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 90 years at the time of signing informed consent
- Iliofemoral disease requiring treatment due to more than 50% stenosis and heavy calcification of the iliac arteries
- Severe symptomatic aortic stenosis with planned TAVR procedure
- Prohibitive iliofemoral disease confirmed by diagnostic CT scan of abdomen and pelvis
- Ability to provide written informed consent
You will not qualify if you...
- Participation in another research study involving an investigational agent without reaching the primary endpoint
- Contraindications to Intravascular Lithotripsy (IVL)
- Contraindications or ineligibility for transcatheter aortic valve replacement (TAVR)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Baylor Scott and White Heart Hospital
Plano, Texas, United States, 75093
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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