Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Baylor Research Institute
50 participants
Mar 30, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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.
Exclusion Criteria3
- Subject is participating in another research study involving an investigational agent that has not reached the primary endpoint.
- Subject who has contraindications to IVL
- Subject who has contraindications or is not eligible for TAVR
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05862558