The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)
The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)
The LOTUS Study is intended to demonstrate the usability of the MICHI Neuroprotection System
 (MICHI NPS) or MICHI Neuroprotection System with filter (MICHI NPS+f) for use in subjects who
 are candidates for Carotid Artery Stenting (CAS). It is a prospective, single arm study in
 which a maximum of 30 study subjects, and a run-in enrollment of up to 10 subjects will be
 followed immediately post-op and at 30 days.
Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe
 adverse neurological effects. Most major clinical studies of CAS have used distal filters for
 cerebral protection and have compared the neurologic complication rates with those of carotid
 endarterectomy (CEA). Many currently available embolic protection devices, however, have
 limited efficacy in capturing microembolic debris liberated during stenting, pre-dilatation
 and post-dilatation. Furthermore, distal protection systems are limited by the need to cross
 the lesion prior to deployment. Some studies have shown a relatively high incidence of
 cerebral infarction even when distal protection devices are employed.

 Cerebral protection with carotid flow reversal is a method that was developed by Parodi, et
 al. (2005), as an alternative to the use of distal protection devices. While novel in its
 approach, this method too has its limitations. Criado, et al. (2004), developed a derivative
 technique that employs carotid flow reversal prior to traversing the stenosis that can be
 accomplished by directly accessing carotid anatomy without the use of the transfemoral
 approach. Major benefits to this method include the ability to perform the procedure on
 patients with severe carotid tortuosity and difficult aortic arch anatomy.
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.

 -  International Normalized Ratio (INR) must be ≤ 1.5 at the time of the procedure
 (subjects taking warfarin may be included if their dose is tapered prior to the
 procedure to meet the inclusion criterion. Dose may be returned to a therapeutic level
 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 is participating in another investigational study that would interfere
 with the conduct or result of this study.

 -  The subject has 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

 -  Total occlusion of the target vessel.

 -  There is an existing, previously placed stent in the target artery.

 -  The subject has a known life-threatening allergy to the contrast media that cannot be
 treated.

 -  Subject has history of intolerance or allergic reaction to any of the study
 medications including aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine
 (Ticlid®), prasugrel heparin or bivalirudin (Angiomax™). Subjects must be able to
 tolerate a combination of aspirin and clopidogrel/ticlopidine or prasugrel.

 -  The subject has a gastrointestinal bleed that would interfere with antiplatelet
 therapy.

 -  The subject has known cardiac sources of emboli.

 -  Subject has Hemoglobin (Hgb) less than 8 gm/dL (unless on dialysis), platelet count <
 50,000/mm3, or known heparin associated thrombocytopenia.

 -  Subject has documented atrial fibrillation in the prior 90 days.

 -  The subject has a history of bleeding diathesis or coagulopathy including
 thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain
 an activated clotting time (ACT) at > 250, or if the subject will refuse blood
 transfusions.

 -  The subject has atherosclerotic disease involving the ipsilateral common carotid
 artery (CCA) that precludes safe placement of the sheath.

 -  The subject has abnormal angiographic findings other than that of the target lesion
 that indicate the subject is at risk for a stroke, 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 or aortic arch
 anatomy.

 -  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 major stroke (NIHSS ≥10) within the previous 30 days of the
 procedure or the patient is considered, by the investigator, to be at high risk for
 hemorrhagic stroke.

 -  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 history of an ipsilateral stroke with fluctuating neurologic symptoms within
 one year prior to the procedure.

 -  Female subjects who are pregnant (negative pregnancy test is required in women of
 childbearing potential).

 -  Subjects, who the Investigator determines, to be at risk of Deep Vein Thrombosis (DVT)