Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Baylor Research Institute
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)
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…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 to 90 years of age, inclusive, at the time of signing the informed consent 2. Iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's). 3. Severe symptomatic aortic stenosis and undergoing a planned TAVR procedure 4. Prohibitive iliofemoral disease, as determined by the diagnostic CT abdomen and pelvis. 5. Subjects can provide written, informed consent. Exclusion Criteria: 1. Subject is participating in another research study involving an investigational agent that has not reached the prim…
Interventions
- DeviceShockwave 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
Location
- Baylor Scott and White Heart HospitalPlano, Texas