ACT I
Carotid Stenting vs. Surgery of Severe Carotid Artery Disease and Stroke Prevention in Asymptomatic Patients
|
Purpose:
To demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield Embolic Protection System and Emboshield Pro Embolic Protection System with the Xact Carotid Stent System to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease.
Interventions:
Carotid artery stenting with filter
Indicated for use as a guidewire and embolic protection system to contain and remove embolic material while performing angioplasty and stenting procedures in carotid arteries.
|
Endarterectomy, carotid
Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.
|
Year Started:
2005
Year Presented:
2010
Design:
Interventional, Other, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
Severe carotid artery disease; patients who have not had symptoms related to their carotid artery disease in the last 180 days; patients who are able to undergo either an interventional stenting or surgical procedure.
Exclusion Criteria
Patients who have had symptoms in the last 180 days; patients who are high risk for surgery; patients who have certain conditions that might confound the results of the study.
Patient Involvement:
Patients will be randomized to either an interventional treatment using a carotid artery stent and filter or the surgical procedure of carotid endarterectomy, on a 3:1 basis. This means that three interventional procedures will be conducted to each surgical (CEA) one, on average, for every four patients.
Primary Outcome:
Occurrence of major adverse events 30 days following the procedure; occurrence of ipsilateral strokes between 31 and 365 days post procedure.
Secondary Outcome:
Acute device success; procedural success; composite morbidity at 0 - 30 days post-procedure.
|
Source of Information:
Correspondence from trial sponsor [August 2005].
ClinicalTrial.gov
Abstract from 2008 ISC.
Presented at the 2008 International Stroke Conference (February 2008).
Presented at the 2010 International Stroke Conference (February 2010).
|
Web Links and Publications:
|
|
This information last updated on: 3/9/2010
Reviewed on: 03/09/2010.
|
Trials
Directories