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

Completed

Phase N/A Results N/A

Eligibility Criteria

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