Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device.

Inclusion criteria

• ≥ 18 years old;
• Eligibility for carotid artery revascularization;
• A significant stenosis in symptomatic patients with ≥ 50% Diameter Stenosis (%DS) or asymptomatic ≥ 80 %DS as defined by angiography.

Symptomatic is defined as a carotid artery stenosis associated with ipsilateral TIA, amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment.

• Suitable clinical conditions to perform DW-MRI.
• Written informed consent as approved by the Ethics Committee of the respective clinical site.

Exclusion criteria

• Female with childbearing potential without a negative pregnancy test.
• Life-expectancy less than 6 months.
• Underlying disease of the carotid artery other than atherosclerosis (e.g. vasculitis, traumatic dissection, fibromuscular dysplasia).
• Prior stenting in the target vessel;
• Patients with chronic or re-current atrial fibrillation.
• Patient has had a Myocardial Infarction within 72 hours prior to the procedure.
• Patient experienced a stroke within 4 weeks prior to the procedure.
• History of severe disabling stroke according to the modified Rankin scale > 4.
• Severe renal failure (serum creatinine > 2.0 mg/dL).
• Severe peripheral arterial occlusive disease, which might impede a safe introduction of a 9F-sheath for the use of a Mo.Ma-device.
• Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Statins, Heparin, Nitinol, contrast agents (that cannot be adequately pre-medicated).
• Patient currently participating in an investigational drug or device study which has not reached the primary endpoint yet or which clinically interferes with the DESERVE study endpoints.
• Any planned major surgery within 30 days after the study procedure.
• In the investigators opinion patient has a severe co-morbid condition(s) that could limit the ability to participate in the study.

Angiographic exclusion criteria:

• Totally occluded internal carotid artery considered as the target vessel.
• Multiple internal carotid artery stenoses or lesion longer than 4 cm (whichever occurs) that cannot be covered by one (1) stent.
• Severe ostial stenosis of the common carotid artery.
• The presence of ipsilateral intracranial stenosis that requires treatment.
• Contralateral occlusion of the internal carotid arteries associated with a poor collateral flow through the circle of Willis.
• An aortic arch anatomical complexity that may preclude the safe placement of the Mo.Ma device including particularly, the impossibility to navigate a stiff guide wire into the external carotid artery.