Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)

Inclusion Criteria:

1. The patient must be > 18 years of age.

2. The patient has a 50% stenosis (as determined by ultrasound or angiogram) of thecommon or internal carotid artery and is clinically symptomatic; i.e., within theprevious 180 days has experienced symptoms in the ipsilateral carotid arterydistribution, defined as:

• one or more TIAs, characterized by distinct focal neurologic dysfunction ormonocular blindness with clearing of signs and symptoms within 24 hours, or

• one or more completed strokes (as defined by this protocol) with persistence ofsymptoms or signs for more than 24 hours (the most recent event is used as thequalifying event), except as excluded below, with stenosis >50%, (as determinedby ultrasound or angiogram) of the common or internal carotid artery, OR Thepatient must have a >80% diameter stenosis (as determined by ultrasound orangiogram) of the internal or common carotid artery without neurologicalsymptoms.

3. To be entered into the study, the patient must have one or more of the followingconditions:

· congestive heart failure (class III/IV) and/or known severe left ventriculardysfunction LVEF < 30%

• open heart surgery within six weeks

• recent MI (>24 hours and <4 weeks)

• unstable angina (CCS class III/IV)

• synchronous severe cardiac and carotid disease requiring open heart surgery andcarotid revascularization

• severe pulmonary disease to include any of the following:

1. chronic oxygen therapy

2. resting PO2 of 60 mmHg

3. baseline hematocrit 50%

4. FEV1 or DLCO 50% of normal. · contralateral carotid occlusion · contralaterallaryngeal palsy · post-radiation treatment · previous CEA recurrent stenosis · highcervical ICA lesions · CCA lesions below the clavicle · severe tandem lesions

• abnormal stress test.

4. The qualifying ultrasound or angiogram was performed less than 30 days prior to studyentry.

· Stenosis >50%: PSV>130 cm/sec; EDV <135 cm/sec

· Stenosis >80%: PSV>220 cm/sec; EDV <135 cm/sec

· PSV ICA/PSV CCA ratio 4.0

5. The target vessel is in the native common or internal carotid artery. The arterialsegment to be treated has a diameter between 4 mm and 9 mm as the largest diameter eitherproximal or distal to the lesion.

Exclusion Criteria:

1. The patient is experiencing an acute ischemic neurologic stroke or has experienced astroke within the past 48 hours.

2. There is any visual angiographic or ultrasound evidence of intraluminal thrombusthought to increase the risk of plaque fragmentation and distal embolization.

3. There is total occlusion of the target carotid artery treatment site.

4. The reference segment diameter (distal common carotid and internal carotid arterysegment cephalic to the lesion) is less than 4mm or greater than 9mm. See InstructionsFor Use, for proper stent sizing. The exception to this would be with a lesion having >95% stenosis where the true diameter of the distal vessel cannot be determined suchas the case with a string sign or distal vessel collapse. In this case the judgment ofthe interventionalist will prevail with the intention not to oversize the stent to thedistal vessel by more than 2mm.

5. The patient has any intracranial aneurysm (> 9 mm).