Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorBaylor Research Institute
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Shockwave Balloon
Treatment groups
No treatment groups listed
Sponsors and collaborators
Baylor Research Institute
Lead sponsor
Shockwave Medical, Inc.
Collaborator
Source ClinicalTrials.gov