ILIT
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
AI Description
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)
- Who can join
- adult, older adult
- Participants
- 50
- Expected completion
- 2027-10-01
- Funded by
- other
Conditions studied
Aortic Valve Stenosis, Iliac Disease
What is being tested
- DEVICE: Shockwave Balloon
What it measures
- Acute technical success per the DISRUPT PAD definition at the time of intervention, Defined as final residual stenosis ≤30% without flow-limiting dissection (≥ Grade D) of the lesion, At time of IVL procedure
- Success rate of transfemoral delivery of a TAVR system post IVL within 30 days of treatment, To know the efficacy of the treatment, At the time of TAVR procedure
Working with
Shockwave Medical, Inc.
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2026-08-21
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.