Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)

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

• Age greater than 80 years as a single risk factor.

Exclusion Criteria:

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

2. The patient has an intracranial mass lesion (i.e., abscess, tumor, or infection).

3. The reference segment diameter (distal common carotid and internal carotid arterysegment cephalic to the lesion) is less than 4mm or greater than 9mm by quantitativeanalysis. See Instructions For Use, for proper stent sizing. The exception to thiswould be with a lesion having >95% stenosis where the true diameter of the distalvessel can not be determined such as the case with a string sign or distal vesselcollapse. In this case the judgment of the interventionalist will prevail with theintention not to oversize the stent to the distal vessel by more than 2mm.

4. The patient has known peripheral vascular, supra-aortic or internal carotid arterytortuosity which preclude the use of catheter-based techniques if so randomized.

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