Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)

Exclusion Criteria

• •1. Life expectancy of less than one year in the opinion of the investigator at the time of enrollment.
• •2. Currently requiring an organ transplantation.
• •3. An evolving acute stroke
• •4. Anticipated or existing potential sources of emboli including left ventricular aneurysm, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area \< 1.0 cm2), endocarditis, moderate to severe mitral stenosis, known previously symptomatic patent foramen ovale (PFO), left atrial thrombus, any intracardiac mass.
• •5. Deep being thrombosis (DVT) or pulmonary embolism (PE) treated within the past 12 months.
• •6. Recently (\< 60 days) implanted heart valve.
• •7. Subject has experienced any episode of paroxysmal atrial fibrillation or atrial flutter within the past 6 months or has a history of paroxysmal atrial fibrillation or atrial flutter requiring chronic anticoagulation.
• •8. History of chronic atrial flutter or chronic atrial fibrillation.
• •9. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, direct thrombin inhibitors, or anti-Xa agents within 14 days of the index procedure.
• •10. Subject with a known hypercoaguable state.
• •11. Acute febrile illness (temperature ≥ 100.4°F or 38°C) or active infection.
• •12. Subject with a SARS-CoV-2/COVID-19 infection within 21 days prior to the index procedure.
• •13. Acute myocardial infarction \< 30 days prior to index procedure.
• •14. Any major surgical procedure (i.e., intraabdominal or intrathoracic surgery or any surgery / interventional procedure involving cardiac or vascular system) 30 days prior to or within 30 days following the index procedure.
• •15. History of disabling stroke with substantial residual disability (modified Rankin score ≥ 3).
• •16. Subject has had a transient ischemic attack (TIA) or amaurosis fugax within 48 hours prior to the index procedure.
• •17. Known severe carotid stenosis contralateral to the target lesion requiring treatment within 30 days of the index procedure.
• •18. Any other neurological deficit not due to stroke that may confound neurological assessments.
• •19. Subject has contralateral laryngeal or vagus nerve injury.
• •20. Subject has severe dementia.
• •21. Subject has intracranial tumor.
• •22. Known hypersensitivity to nitinol or its components (e.g., nickel, titanium).
• •23. History of intracranial hemorrhage within the 12 months prior to the index procedure.
• •24. History of gastrointestinal (GI) bleed within 30 days prior to the index procedure that would interfere with antiplatelet therapy.
• •25. Any condition that precludes proper angiographic assessment or makes direct carotid artery access unsafe (e.g., severe hepatic impairment, malignant hypertension, morbid obesity).
• •26. Subject has less than 5 cm between the direct carotid access site and the proximal edge of the target lesion.
• •27. Known hypersensitivity to contrast media that cannot be adequately premedicated.
• •28. Hemoglobin (Hgb) \< 8 gm/dL, platelet count \< 100,000, international normalized ratio (INR) \> 1.5 (irreversible), or heparin-induced thrombocytopenia.
• •29. Chronic renal insufficiency (serum creatinine \> 2.5 mg/dL or estimated GFR \< 30 cc/min) or end-stage renal disease on hemodialysis on the day of the index procedure.
• •30. History or current indication of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain an activated clotting time (ACT) at ≥ 250 seconds, or uncorrectable severe anemia.
• •31. Contraindication, intollerance or allergy to standard of care study medications, including antiplatelet therapy or aspirin.
• •32. Previously enrolled in this study or currently enrolled in another interventional device or drug study that has not yet reached the primary endpoint.
• •33. Potential for subject non-compliance with protocol-required follow up or antiplatelet medication in the opinion of the investigator.
• •34. Subject is otherwise unsuitable for intervention or surgery in the opinion of the investigator.
• •1. Total occlusion of the target carotid artery.
• •2. Previously placed stent in the target vessel or the planned arteriotomy site.
• •3. Excessive circumferential calcification of the target lesion, defined as \> 3 mm of thickness of calcification seen in orthogonal views on fluoroscopy or on CTA.
• •4. Qualitative characteristics of ipsilateral common carotid artery, ipsilateral external carotid artery, or target lesion that preclude or make difficult the safe introduction of the direct access sheath.
• •5. Angiographic evidence of a mobile filling defect or fresh thrombus in the target carotid artery.
• •6. Presence of "string sign" of the target lesion (a sub-totally occluded, long segment of the true lumen of the artery with markedly reduced contrast flow).
• •7. Non-atherosclerotic carotid stenosis (e.g., dissection, fibromuscular dysplasia).
• •8. Proximal/ostial CCA stenosis ≥ 50% or intracranial stenosis more severe than the target lesion.
• •9. Subject in whom direct carotid access is not possible, including severe tortuosity or stenosis that requires additional endovascular procedures or that prevents safe and expeditious vascular access.
• •10. Subject with intracranial pathology, that in the opinion of the investigator, makes the patient inappropriate for study participation (e.g., arteriovenous malformation, intracranial tumor, microangiopathy or large vessel cerebral vascular disease, etc.) or that would confound the neurological evaluation.
• •11. Angiographic, CT, MR or ultrasound evidence of atherosclerosis of the common carotid artery that would preclude or make difficult safe placement of the sheath and other endovascular devices to the target artery as needed for carotid stenting.
• •12. Angiographic, CT, MR or ultrasound evidence of severe tortuosity of the cervical internal carotid artery. Severe vascular tortuosity is defined as 2 or more bends of 90 degrees or more within 4 cm of the target lesion.
• •13. Angiographic, CT, MR or ultrasound evidence of angulation or tortuosity (≥ 90 degree) of the common carotid artery (CCA) that will transmit a severe loop to the internal carotid after sheath placement.
• •14. Subject with \> 50% stenosis in the common carotid artery (CCA) proximal to the target lesion.