PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON)

Inclusion Criteria:

• Male and female ≥ 18 years old;
• Suitable/Eligible for carotid artery revascularization;
• Significant artery stenosis in symptomatic patients defined as ≥ 50% of the artery diameter (%DS) or asymptomatic ≥ 80 %DS by angiography. Symptomatic is defined as a carotid artery stenosis associated with ipsilateral transient ischemic attack (TIA), amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment.
• Adequate clinical conditions to perform DW-MRI.
• Ability of the individual to understand the character and the consequences of clinical trial.
• Signed and dated informed consent provided before the beginning of any intervention.
• Negative pregnancy test (serum or urine) and contraception use for any woman of childbearing age. Systematic contraceptives (oral, implant, injection) and dia-phragm or condoms with spermicidal are considered reliable. Women who have undergone bilateral oophorectomy or/and hysterectomy or women status post-menopausal for at least two years are eligible for this trial.

Exclusion Criteria:

• Intracranial hemorrhage, hemorrhagic stroke, or stroke with mass effect demonstrated on CT scan or MRI within 30 days of the index procedure.
• Persisting ischemic stroke (defined as either a score > 15 on the NIH stroke scale, a Rankin score > 3 or a Barthel score < 60 measured within one week prior to study entry).
• Intracranial mass lesion (i.e., abscess, tumor, or other infection).
• peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding the use of catheter-based techniques required for successful results.
• Lactation.
• Arterio-venous malformation in the territory of the target carotid artery.
• Any disease or medication that affects local hemostasis,
• Participation in other clinical trials during the present clinical trial or within the last month.
• Medical or psychological condition that would not permit completion of the trial or signing of informed consent.