Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting


Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

1. Patient is at least 18 years old;
2. Patient is willing and capable of complying with the study protocol requirements, including the specified follow-up period;
3. Patient is willing to provide written informed consent prior to enrollment in the study;
4. Male, infertile female, or non-lactating female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7-days prior to study procedure;
5. Patient is either symptomatic, i.e. with a history of TIAs or non-disabling stroke within 6 months of the procedure, with carotid stenosis ≥ 50%, or asymptomatic with carotid stenosis ≥ 80%, as diagnosed by angiography using NASCET methodology;4
6. The target lesion is located in the internal carotid artery (ICA) and the reference vessel diameter, i.e. the common carotid artery (CCA) is < 10 mm based on angiographic assessment.

Exclusion Criteria

1. Acute evolving or recent stroke within 7 days of study evaluation;
2. Cardiac embolism;
3. Acute myocardial infarction less than 72 hours prior to the procedure;
4. Major surgical procedure within 30 days preceding CAS;
5. Major surgical procedure within 30 days after the index procedure;
6. Prior major ipsilateral stroke with residual deficit or other neurologic conditions that may affect neurological assessments;
7. Pregnancy or breastfeeding;
8. Severe chronic renal insufficiency (serum creatinine is ≥ 2.5 mg/dL);
9. Contraindication to study medications, including antiplatelet therapy;
10. Prior sensitivity to contrast media that cannot adequately be controlled with pre-medication;
11. Untreatable bleeding diathesis or hypercoagulable state or refusal to blood transfusions;
12. History of uncontrolled pulmonary hypertension;
13. Intracranial pathology;
14. Patient unable or unwilling to undergo DW-MRI of the brain
15. Patient without adequate transtemporal window for transcranial Doppler examination
16. Other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
17. Isolated ipsilateral hemisphere leading to subject intolerance to flow reversal;
18. Anatomic conditions that preclude performance of carotid artery stenting.