Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study

Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study

The purpose of this study is to get outcomes data for the Adapt Monorail Carotid System used in conjunction with the FilterWire Embolic protection system for treatment of patients that suffer from carotid artery stenosis and that cannot have surgery due to high risk factors.

According to the World Health Organization, 15 million people suffer stroke each year. Of these, 5 million die and another 5 million are permanently disabled. Predominant mechanism responsible for stroke is embolism from proximal rupture of atherosclerotic plaque and thrombus. 25-30% of stroke deaths related to the carotid stenosis. The primary therapy for carotid occlusive disease is the surgical removal of this atherosclerotic plaque from inside the artery. Another treatment option for subjects with significant surgical risk factors has been found: the carotid artery stenting is a non-surgical procedure which unblocks narrowing of the carotid artery lumen by inserting a small metal tube (stent) to keep the plaque against the wall of the artery to improve blood flow.

Inclusion Criteria:

• High-risk for carotid endarterectomy due to anatomical or co-morbid conditions and either has neurological symptoms and ≥ 50% stenosis, via angiography or is asymptomatic and has ≥ 80% stenosis, via angiography
• Target lesion located in the common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation
• Arterial segment to be stented has a diameter between 4mm and 9mm
• Age ≥ 18 years
• Life expectancy > 12 months from the date of the index procedure

Exclusion Criteria:

• Contraindication to percutaneous transluminal angioplasty (PTA)
• Severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system
• Lesions in the ostium of the common carotid artery
• Occlusion of the target vessel
• Evidence of intraluminal thrombus
• Known sensitivity to nickel-titanium
• Known allergy to heparin, aspirin or other anticoagulant/ antiplatelet therapies, or is unable or unwilling to tolerate such therapies
• Uncorrectable bleeding disorders, or will refuse blood transfusions
• History of prior life-threatening contrast media reaction
• Previous stent placement in the target vessel
• Evolving stroke or intracranial hemorrhage
• Previous intracranial hemorrhage or brain surgery within the past 12 months
• Clinical condition that makes endovascular therapy impossible or hazardous