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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00316108 |
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).
Condition | Intervention |
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Carotid Artery Diseases Stroke Cerebral Arteriosclerosis |
Device: WALLSTENT® Endoprosthesis™ |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients |
Enrollment: | 747 |
Study Start Date: | February 2002 |
Study Completion Date: | November 2007 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
Device: WALLSTENT® Endoprosthesis™
Carotid Artery Stent
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key General Inclusion Criteria:
A. Symptomatic: Carotid stenosis of greater than or equal to 50% via angiography with associated cerebral or retinal TIA or ischemic stroke symptoms within 180 days of the procedure, which are determined to have occurred in the cerebral hemisphere or eye ipsilateral to the target carotid artery lesion and to be reasonably attributable to that lesion; or
B. Asymptomatic: Carotid stenosis greater than or equal to 80% via angiography without associated cerebral or retinal TIA or ischemic stroke symptoms within 180 days of the procedure.
Key High-Risk Eligibility Inclusion Criteria:
Patients must qualify in at least one high-risk category. The high-risk categories are defined as:
Exclusion Criteria:
Pre-existing stent(s):
Principal Investigator: | Christopher White, MD | Ochsner Clinic Foundation |
Principal Investigator: | Sriram Iyer, MD | Lenox Hill Heart and Vascular Institute |
Study Director: | Pamela G Grady, Ph.D | Boston Scientific Corporation |
Responsible Party: | Boston Scientific ( Christina Drager ) |
Study ID Numbers: | S5385, COR2000001U |
Study First Received: | April 18, 2006 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00316108 |
Health Authority: | United States: Food and Drug Administration |
Carotid Carotid Artery Stenting Stent Carotid Endarterectomy |
Stroke Transient Ischemic Attack Stenosis Atherosclerotic Disease |
Arterial Occlusive Diseases Ischemic Attack, Transient Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Constriction, Pathologic Arteriosclerosis |
Ischemia Brain Diseases Intracranial Arterial Diseases Cerebrovascular Disorders Intracranial Arteriosclerosis Embolism Carotid Artery Diseases |
Nervous System Diseases Cardiovascular Diseases |