Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study)

1. Age ≥ 18 years.

2. Patient is able and willing to comply with all assessments in the study.

3. Patient has been informed of the nature of the study, agrees to participate and has signed the approved informed consent form.

4. Patient approved for inclusion by a Patient Screening Committee.

5. Patient must have a life expectancy \> 1 year at the time of the index procedure, in the opinion of the investigator at the time of enrollment, with no planned major cardiac intervention or surgery within 30 days following the index procedure.

6. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the carotid bifurcation.

7. Target lesion must meet all requirements for commercially available trans-femoral stent systems (refer to IFU for requirements) and investigator intends to treat the target lesion with a single stent.

8. Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis by duplex ultrasound in combination with CT or MR angiography:

1. Symptomatic: ≥ 50% stenosis of the internal carotid artery and the patient has a history of stroke, TIA and/or amaurosis fugax within 180 days of the procedure ipsilateral to the carotid artery to be treated.

OR

2. Asymptomatic: ≥ 70% stenosis of the internal carotid artery without any neurological symptoms.

9. Patient has evidence of circumferential calcification of the stenotic lesion defined as ≥ 3 mm thickness of calcification as determined by Computed Tomography Angiography (CTA). MR angiography may be used in place of CTA for patients with a relative or absolute contraindication to CTA.

10. Patient is high risk for CEA defined as meeting at least one anatomic or clinical high-risk condition listed below:

Target lesion at or above C2 (level of jaw) or below the clavicle

Inability to extend the head due to cervical arthritis or other cervical disorders

History of radiation treatment to the neck or radical neck dissection

Prior head and neck surgery in the region of the carotid artery

Spinal immobility of the neck

Tracheostomy or tracheostoma

Hostile neck or surgically inaccessible lesion

Laryngeal palsy or laryngectomy

Severe tandem lesions (total length must be ≤ 30 mm and must be covered with one stent)

Occlusion of the contralateral CCA or ICA

Severe bilateral ICA stenosis

Patient is ≥ 70 years of age.

Patient has congestive heart failure (CHF) - New York Heart Association (NYHA) Functional Class III or IV.

Patient has severe pulmonary disease (COPD) with either FEV \< 50% predicted or chronic oxygen therapy or resting PO2 of \< 60 mmHg (room air).

Patient has a history of angina Canadian Cardiovascular Society (CCS) class 3 or 4 or unstable angina.

Patient has known severe left ventricular dysfunction LVEF \< 30%.

Patient had a myocardial infarction \> 72 hours and \< 6 weeks prior to procedure.

Coronary artery disease with two or more vessels with ≥ 70% stenosis.

Planned coronary artery bypass grafting (CABG) or valve replacement surgery between 31 and 60 days after index procedure.

Patient has permanent contralateral cranial nerve injury/paralysis.

Patient has chronic renal insufficiency (serum creatinine ≥ 2.5 mg/dL). Note that patients on dialysis are excluded from study consideration per exclusionary criterion #13.

Planned abdominal aortic aneurysm repair or peripheral vascular surgery between 31 to 60 days after index procedure.

What this study is about