Stent-protected Percutaneous Angioplasty of the Carotid vs. Endarterectomy "SPACE"

Completed

Phase N/A Results

Eligibility Criteria

Inclusion Criteria

Patients with severe carotid stenosis (>= 70% by Duplex sonography, >= 50% by NASCET criteria, or >= 70% by ECST criteria ) who have experienced amaurosis fugax, transient ischemic attack (TIA), prolonged reversible ischemic neurological deficit (PRIND), or other mild stroke within 180 days of randomization, and who have a modified Rankin scale (MRS) score =< 3, will be eligible for this trial.
TIA, amaurosis fugax, or non-disabling stroke (mod. Rankin <= 3) occurring within 180 days in patients

Exclusion Criteria

Pregnant females, and persons with a history of intracranial bleeding within 90 days of randomization, who have a confirmed arteriovenous malformation or aneurysm, who have a serious comorbid illness limiting life expectancy to less than 2 years, who have an uncontrolled coagulopathy, who have any contraindication for heparin, ASA, clopidogrel, or contrast media, who have stenosis or dissection of the common and/or internal carotid arteries, who have stenosis following surgical or endovascular pretreatment, whose stenoses result from radiation therapy, fibromuscular dysplasia, or endovascular thrombosis, who have tandem stenoses (if the distal stenosis is the more severe), who have other planned surgical interventions, or who have any comorbid condition that, in the opinion of the investigator, would interfere with the study, will be excluded from this trial.