Shockwave: Disruption for A Better Fit

Study Overview
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Brief Summary
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Recent clinical trial results demonstrate that IVL can increase lumen area by emitting sonic pressure waves, with less inflation pressure as compared to traditional angioplasty balloon dilation and resulting in minimal trauma to the vessel. Therefore, the use of IVL prior to placement of a stent for severely calcified femoral popliteal arteries may be associated with more successful stent implants and better long-term patency, resulting in a decrease in cardiovascular events. The investigator will evaluate the success by defining as lesion stenosis less than 30% and no evidence of Major Adverse Cardiac Event including death or any amputation of the index limb within 30 days of the procedure.

Detailed Description
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The purpose of this study is to evaluate the immediate and long term effectiveness of using intravenous lithotripsy followed by the placement of a Supera stent for the treatment of calcified femoral popliteal arteries. The use of IVL and Supera stent will be predetermined by the investigator according to inclusion criteria and the need for treatment and stenting combined, will be confirmed through the use of intravascular ultrasound and the investigators judgment for best practice. Following enrollment and index procedure, the subject will be followed prospectively for one year.

Official Title
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Shockwave: Disruption for A Better Fit

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Shockwave Intravenous lithotripsy with a Supera stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years Treatment for de novo, densely calcified femoral popliteal arteries with 70-100% stenosis as measured by IVUS. Lesion lengths up to 140 mm. Planned follow-up within the health clinic. Exclusion Criteria: Calcified femoral popliteal arteries that show <70% stenosis by angiography. Calcified femoral popliteal arteries with 100% stenosis in which the lesion cannot be crossed after pre-dilation with a 2-3mm balloon. Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension). Thrombophlebitis or deep venous thrombus, within the previous 30 days. Evidence of end stage renal disease (ESRD) or stage 5 chronic kidney disease (CKD). Currently receiving treatment in an investigational device or drug study or anticipate participating in an investigational device or drug study for the duration of this study. Anticipated life expectancy less than 6 months. Lack of phone or email for contact.

Ages Eligible for Study
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Minimum Age: 18 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 Intravenous lithotripsy with a Supera stent|Pre-dilation with the option of using a 2-3mm balloon to cross a lesion for lithotripsy with the shockwave device followed by placement of supera stent.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | determining effectiveness of the procedure will be defined as final residual stenosis of <30% post-stent placement, as measured by IVUS. | immediately after the intervention | 
| Major adverse cardiac events | a composite of Major Adverse Cardiac events (MACE) including death and any amputation of the index limb within 30 days. Study success will be defined as those patients who meet both the effectiveness and safety objectives. | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in minimum lumen area | the change in minimum lumen area following IVL treatment measured in mm2 by intravenous ultrasound | immediately following intervention | 
| Patency of index vessel | primary patency rate of ≥80% measured by extravascular ultrasound | up to 6 months | 
| Extended patency of index vessel | long term patency of index vessel of ≥80% measured by extravascular ultrasound | 1 year | 
| improved ankle-brachial index | an increase in ankle-brachial index measured by the ankle pressure in mmHg divided by the brachial pressure in mmHg | 1 year |