Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Study Overview
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Brief Summary
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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)

Detailed Description
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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 for alternative access, will be considered for the study. The medical devices being used are in the post-market stage as it is being used in accordance with its approved labeling, treating iliofemoral disease. Study data will be recorded prospectively on dedicated Data Collection Forms and stored locally in a secure format. De-identified data will be uploaded for statistical analysis. IRB approval for the study will be obtained.

Official Title
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR

Conditions
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Iliac Disease, Aortic Valve Stenosis

Intervention / Treatment
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* Device: Shockwave Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Shockwave 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At IVL procedure | 
| 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. | 1 year after IVL procedure |