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
This trial does not accept healthy volunteersQualifiers
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 population
Subjects must meet the inclusion criteria and have none of the exclusion criteria to be eligible for participation in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Shockwave Balloon
DeviceIntravascular 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
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
At time of IVL procedure2
Success rate of transfemoral delivery of a TAVR system post IVL within 30 days of treatment
To know the efficacy of the treatment
Time frame
At the time of TAVR procedureSecondary outcomes
1
Applicable VARC-3 criteria at the time of peripheral intervention for bleeding, access site and access related complications.
To understand the efficacy of the treatment
Time frame
At IVL procedure2
Major adverse events within 1 year
need for emergency surgical revascularization of target limb, unplanned target limb major amputation (above the ankle), symptomatic thrombus or distal emboli that requires surgical, mechanical, or pharmacologic means to improve flow and extend hospitalization, perforations that require an intervention, including bail-out stenting.
Time frame
1 year after IVL procedureSponsors and contacts
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Baylor Research Institute
Lead sponsor
Shockwave Medical, Inc.
Collaborator
Source ClinicalTrials.gov