Proximal Protection With The Mo.Ma Device During Carotid Stenting

Test Device:

Mo.Ma™ Proximal Flow Blockage Cerebral Protection Device. Single size catheter device with a
9 French introducer sheath compatible shaft (outer diameter) and a 6 French compatible
working channel (inner diameter), integrating two compliant balloons intended to achieve
endovascular clamping of external carotid arteries (ECA) 3-6 mm in diameter and common
carotid arteries (CCA) 5-13 mm in diameter.

Primary Objective:

Evaluate the safety and effectiveness of the Mo.Ma device for cerebral protection in the
treatment of internal carotid artery (ICA) stenoses, which may or may not involve the
bifurcation of the CCA, in subjects considered to be at high surgical risk for complications
during carotid endarterectomy (CEA).

Primary Endpoint:

Major adverse cardiac and cerebrovascular events (MACCE) within 30 days of implantation.
MACCE are defined as: any myocardial infarction (MI), stroke, or death through day 30
post-procedure.

General inclusion criteria Subject meets one or more of the high surgical risk criteria.

- Subject is ≥ 18 years old.

- Subject is a candidate for single lesion carotid artery stenting using a femoral
arterial approach.

- Subject is willing and able to comply with follow-up evaluations at the specified
times.

- Subject (or legal representative) understands the nature of the procedure and
provides informed consent, prior to enrollment in the study.

- If female subject, is not currently pregnant and has stated that she has no intention
of becoming pregnant during the study.

Angiographic inclusion criteria (as determined ≤ 30 days prior to procedure):

- Target lesion stenosis (% stenosis = (1-N/D) X 100)1, documented by selective
angiography pre-intervention, is

- ≥ 80% stenosis for asymptomatic subjects or

- ≥ 50% stenosis for symptomatic subjects. Symptomatic is defined as carotid
stenosis associated with ipsilateral transient or visual TIA evidenced
byamaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral ischemic stroke
within 6 months prior to enrollment.

- Target lesion is within the internal carotid artery and/or involves the bifurcation
of the CCA.

- External carotid artery diameter where the Mo.Ma device will be positioned is 3-6 mm.

- Common carotid artery diameter where the Mo.Ma device will be positioned is 5-13 mm.

General exclusion criteria

- Subject has participated in, is participating in, or plans to participate in another
clinical study that may affect either the pre-procedure or follow-up results.

- Subject has chronic or paroxysmal atrial fibrillation that is not treated by
Coumadin.

- Subject has undergone prior stenting of the ipsilateral carotid artery.

- Subject's life expectancy is less than twelve months.

- Subject is unable to respond to external questions and stimuli and to exert a
pressure with the contralateral hand.

- Subject is suffering from dementia.

- Subject has documented intolerance to BOTH heparin and Angiomax.

- Subject has an allergy or contraindication to acetylsalicylic acid (ASA).

- Subject has a documented allergy to the device materials.

- Subject has a documented allergy to radiographic contrast that cannot be pre-treated.

- Subject has a documented allergy or contraindication to BOTH clopidogrel and
ticlopidine.

- Subject has had active bleeding diathesis requiring blood transfusion within one (1)
month prior to index procedure.

- Subject has had an MI within 72 hours prior to carotid stenting.

- Subject has had coronary artery bypass graft (CABG) or vascular surgery within 30
days PRIOR TO index procedure (percutaneous coronary intervention is permissible
provided cardiac enzymes are normal within 24 hours of index procedure), OR has
planned CABG, vascular surgery, percutaneous coronary intervention (PCI), or has
other invasive medical procedures planned within 30 days AFTER index
procedure.(Unplanned urgent or emergent procedures may be performed at anytime as
clinically indicated).

- Subject has a major residual neurological deficit (stroke scales: Barthel ≤ 60, NIH ≥
15 or Rankin > 3) at pre-procedure neurological exam.

- Subject has had a transient ischemic attack (TIA) or amaurosis fugax within 48 hours
prior to index procedure.

- Subject has had a stroke or retinal artery occlusion within one (1) month prior to
index procedure.

- Subject had abnormal pre-intervention blood counts with platelets < 50,000/cubic mm
or > 700,000/cubic mm or white blood cell count < 3,000/cubic mm.

- Subject has severe chronic renal failure (creatinine > 2.5 mg/dl).

- Subject is currently being treated for cerebral carcinoma or sarcoma.

- Subject has peripheral vascular disease, which precludes safe femoral artery sheath
insertion.

- Subject is unable or unwilling to undergo insertion of a temporary pacemaker.

Angiographic exclusion criteria (as determined ≤ 30 days prior to procedure):

- The target carotid artery is completely occluded.

- The common carotid artery ostium has stenosis that requires treatment.

- Multiple carotid stenoses exist in the internal carotid artery (ICA) that cannot be
covered by one stent.

- The presence of ipsilateral intracranial stenosis that requires treatment.

- The presence of any intracranial tumor(s), arteriovenous malformation(s) (AVMs), or
aneurysm(s) requiring treatment.

- The inability to position a stiff .035" guidewire in the external carotid artery
(ECA).

- Contralateral occlusion of internal carotid artery and vertebral arteries.

- Aortic arch anatomical anomalies that preclude the safe placement of the device.