Stroke Clinical Trial
Official title:
Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients
The purpose of this study is to determine whether morbidity and mortality for high-risk surgical patients treated with the Carotid Wallstent in conjunction with the FilterWire EX and EZ System distal protection device will be less than or equal to that of objective performance criteria (OPC) derived from historic controls undergoing surgical intervention with a carotid endarterectomy (CEA).
Stroke is the third leading cause of death in this country with approximately 600,000 new
stroke cases each year. Mortality rates as high as 40 percent have been reported for stroke
as a result of ischemia associated with the carotid distribution. Currently, the primary
therapy for carotid artery occlusive disease is carotid endarterectomy (CEA) or the surgical
removal of atheromatous material from inside the artery.
Although CEA is an effective treatment for the majority of patients with carotid occlusive
disease, there remains a need for a treatment option for those patients with significant
surgical risk factors. These patients have been shown to have much higher rates of morbidity
and mortality. There are approximately 50,000-70,000 patients each year who are considered
poor surgical candidates. These patients present with either one or more anatomical or
co-morbid conditions and have a one-year stroke and death rate of up to 15% with traditional
surgical treatment.
Carotid artery stenting (CAS) has been reported by numerous single-center trials to be
feasible in the treatment of carotid artery stenosis. Moreover, the risk benefit ratio has
been suggested to be the largest in those patients with a higher risk profile for the CEA
treatment option.
This trial will study the effects of percutaneous intervention using the Monorailâ„¢ Carotid
Wallstent® Endoprosthesis (Carotid Wallstent) in conjunction with the FilterWire System
distal protection device (FilterWire EX and EZ) on rates of common peri-procedural
complications as well as on long-term outcomes as compared to historical outcomes of
patients undergoing CEA.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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