Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)
Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)
The primary objective of this study is to compare the safety and effectiveness of the Cordis
 Nitinol Carotid Stent and Delivery Systems (5.5 F and 7 F) with the ANGIOGUARD XP distal
 protective device to CEA in the treatment of carotid artery disease in patients at increased
 risk for surgery.
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 the
 common or internal carotid artery and is clinically symptomatic; i.e., within the
 previous 180 days has experienced symptoms in the ipsilateral carotid artery
 distribution, defined as:

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

 -  one or more completed strokes (as defined by this protocol) with persistence of
 symptoms or signs for more than 24 hours (the most recent event is used as the
 qualifying event), except as excluded below, with stenosis >50%, (as determined
 by ultrasound or angiogram) of the common or internal carotid artery, OR The
 patient must have a >80% diameter stenosis (as determined by ultrasound or
 angiogram) of the internal or common carotid artery without neurological
 symptoms.

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

 -  congestive heart failure (class III/IV) and/or known severe left ventricular
 dysfunction 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 and
 carotid 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 a
 stroke 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 artery
 segment cephalic to the lesion) is less than 4mm or greater than 9mm by quantitative
 analysis. See Instructions For 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 can not be determined such as the case with a string sign or distal vessel
 collapse. In this case the judgment of the interventionalist will prevail with the
 intention 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 artery
 tortuosity which preclude the use of catheter-based techniques if so randomized.

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