Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting

Inclusion Criteria:

1. Subject is willing and able to provide appropriate study-specific informed consent,follow protocol procedures, and comply with follow-up visit requirements.

2. Subject is willing and able to take dual antiplatelet therapy for a minimum of 30days.

3. Life expectancy ≥ 24 months from the date of the index procedure.

4. Females who are not pregnant or lactating and not planning to become pregnant forthe duration of the study.

5. Subject has a modified Rankin Score of ≤ 2at the time of informed consent.

6. Subject is diagnosed with carotid artery disease treatable with carotid arterystenting and is considered high risk for carotid endarterectomy (CEA) as evidencedby:

7. Symptomatic carotid stenosis ≥ 50%. Symptomatic is defined as amaurosis fugax,transient ischemia attack (TIA) or stroke within the last 6 months ipsilateralto the side of the stenosis.Or

8. Asymptomatic carotid stenosis ≥ 80%

9. Co-Morbidity High Risk Conditions for CEA, i.e., meets one or more of the followingcriteria:

10. Age ≥ 70 (maximum 80 years)

11. CCS angina class 3-4 or unstable angina

12. Congestive Heart Failure (CHF) NYHA class III-IV

13. Left ventricular ejection fraction (LVEF) ≤ 35%

14. MI ≥ 72 hours and < 6 weeks pre-procedure

15. Multi-vessel CAD (≥ 2 vessels >70% stenosis) and history of angina

16. Chronic Obstructive Pulmonary Disease (COPD) with FEV1<50

17. Permanent contralateral cranial nerve injury/paralysis

18. Restenosis from previous carotid endarterectomy (CEA)

19. Planned coronary artery bypass grafting (CABG) or valve replacement surgerybetween 31-60 days after CAS

20. Abdominal aortic aneurysm repair or peripheral vascular surgery is plannedbetween 31 to 60 days after CAS. OR

21. High Anatomical Risk for CEA, i.e., meets one or more of the following criteria:

22. Occlusion of the contralateral CCA or ICA.

23. Prior radiation treatment to the neck or a radical neck dissection.

24. Severe bilateral ICA stenosis requiring treatment.

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

26. Severe tandem lesions

27. Inability to extend the hear due to cervical disorders.

28. Laryngeal palsy or laryngectomy.

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

30. Tracheostomy or tracheostoma.

31. Spinal immobility of the neck.

32. Hostile neck or surgically inaccessible lesion.

33. Angiographic General Inclusion Criteria, i.e., meets all the following criteria:

34. Target lesion location at the carotid bifurcation and/or proximal internal carotidartery (ICA)

35. Vessel distal to target lesion can accommodate a distal embolic protection device (EPD), and EPD is compatible with CGuard™ device (refer to CGuard™ System IFU forspecific EPDs).

36. Target vessel reference diameter at stent landing zone is 4.8 mm to 9.0 mm.

37. Target lesion length ≤ 36 mm, that can be covered by a single CGuard™ stent.

Exclusion Criteria:

1. Planned interventional procedure or surgery of the carotid, coronary or peripheralarteries within 30 days before or after the index carotid procedure.

2. Severe vascular anatomy that would preclude safe sheath insertion, deliverability ofstent or embolic protection device.

3. Type III or bovine aortic arch.

4. Total occlusion of the target vessel.

5. Presence of "String sign" of the target lesion.

6. In-tandem lesions with >= 50% or >= 80% diameter stenosis for symptomatic orasymptomatic patients, respectively, which cannot be covered by a single CGuard™stent.

7. History of bleeding diatheses or coagulopathy or inability to accept bloodtransfusions.

8. Bilateral carotid stenosis requiring treatment on both sides within 30 days prior toor following planned index procedure.

9. Subject is on renal replacement therapy or has Stage 4 or 5 Chronic Kidney Disease (CKD).

10. Known reason for potential stroke other than carotid artery stenosis, includinghistory of atrial fibrillation or other sources of thromboemboli within the past 12months.

11. History of thrombophilia.

12. Known sensitivity or allergy to nitinol, titanium, heparin, aspirin or otheranticoagulant/ antiplatelet therapies.

13. Contrast media sensitivity or allergy that cannot be pre-treated.

14. Previous stent placement in the target vessel.

15. Evolving stroke or intracranial hemorrhage, or history of previous intracranialhemorrhage or brain surgery within the past 12 months.

16. Major neurologic deficit with NIHSS of ≥ 15.

17. Dementia or other neurologic condition confounding the neurologic assessment.

18. Clinical condition that, in the opinion of the investigator, makes endovasculartherapy impossible or hazardous.

19. Subject previously enrolled in this clinical trial.

20. Possible / probable non-compliance of subject with protocol required follow up ormedication.

21. Subject is currently participating in another clinical trial that has not completedits primary endpoint assessment or would confound this C-GUARDIANS Pivotal IDEClinical Study.

22. SARS-CoV2 (COVID-19) active infection.