NCT00316108

Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)

Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 747 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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 Monorail™ 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.

Conditions

• Carotid Artery Diseases
• Stroke
• Cerebral Arteriosclerosis

Interventions

Type	Name	Description
DEVICE	WALLSTENT® Endoprosthesis™	Carotid Artery Stent

Timeline

• Start date: 2002-02-01
• Primary completion: 2005-05-01
• Completion: 2007-11-01
• First posted: 2006-04-20
• Last updated: 2014-08-28

Locations

50 sites across 1 country: United States