Silk Road Medical First in Man Study - Neuroprotection During Carotid Stenting and Angioplasty

Inclusion Criteria

• Subject must be > 21 years of age.
• Subject has the ability to understand and cooperate with study procedures and agrees to return for all required follow-up visits, tests and exams.
• Subjects taking warfarin may be included if their dosage is reduced before the procedure to result in an International Normalized Ratio (INR) of 1.5 or less. Warfarin may be restarted to therapeutic dose after the procedure.
• The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local medical ethics committee (EC).
• The life expectancy of the subject is at least one year.
• The subject has a lesion located in the internal carotid artery (ICA); the carotid bifurcation may be involved.
• The subject must have a minimum distance of 5 cm between the clavicle and bifurcation, as assessed by duplex Doppler ultrasound, computed axial tomographic (CT) angiography or magnetic resonance (MR) angiography.

Exclusion Criteria

• The subject was participating in another investigational trial that would interfere with the conduct or result of this study.
• The subject had dementia or a neurological illness that may confound the neurological evaluation.
• Presence of any one of the following anatomic risk factors:
• Previous radiation treatment to the neck or radical neck dissection
• Tracheostomy or tracheal stoma
• Laryngectomy
• Contralateral laryngeal nerve palsy
• Severe tandem lesions
• Inability to extend the head due to cervical arthritis or other cervical disorders
• A total occlusion of the target vessel.
• There was an existing, previously placed stent in the target artery.
• The subject had a known life-threatening allergy to the contrast media that cannot be treated.
• Subject had history of intolerance or allergic reaction to any of the study medications including aspirin, Clopidogrel bisulfate (Plavix®) or Ticlopidine (Ticlid®), heparin or Bivalrudin (Angiomax™). Subject was unable to tolerate a combination of aspirin and Clopidogrel/Ticlopidine.
• The subject had a GI bleed that would interfere with antiplatelet therapy.
• The subject had known cardiac source of potential emboli.
• Subject had a Hemoglobin (Hgb) level less than 8 gm/dL (unless on dialysis), platelet count 250, or will refuse blood transfusion.
• The subject had atherosclerotic disease involving in the ipsilateral common carotid artery that precluded safe placement of the arterial sheath.
• The subject has other abnormal angiographic findings that indicate the subject is at risk for a stroke due to a problem other than that of the target lesion, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation of the cerebral vasculature.
• There is evidence of a carotid artery dissection prior to the initiation of the procedure.
• There is an angiographically visible thrombus.
• There is any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe, e.g. morbid obesity, sustained systolic blood pressure > 180 mm Hg, tortuosity, occlusive disease, vessel anatomy, aortic arch anatomy, or cerebral protective system.
• Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.
• There is evidence of bilateral carotid stenosis that would require intervention within 30 days of procedure.
• There is evidence of a stroke within the previous 30 days of the procedure.
• There is a planned treatment of a non-target lesion within 30 days post procedure.
• There is a history of intracranial hemorrhage within the previous 3 months, including hemorrhagic transformation of an ischemic stroke.
• There is a history of an ipsilateral stroke with fluctuating neurologic symptoms within one year of the procedure.
• Female subjects who are pregnant or may become pregnant.