Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)

Carotid Artery Disease - ACT 1

Trial Sponsor
Abbott Vascular

Principal Investigator
Gregory J. Mishkel, MD

Trial Name
Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)

Purpose
The study is being conducted 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.

Details
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.

Phase
Phase III

Study Type
Interventional

Study Design
Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Arms
2

Expected Enrollment
1858

Study Start
April 2005

Expected Completion
April 2014

Primary Outcome Measures

Occurrence of major adverse events 30 days following the procedure
Occurrence of ipsilateral strokes between 31 and 365 days post procedure

Secondary Outcome Measures

Acute device success
Procedural success
Composite morbidity at 0 - 30 days Post-Procedure

Eligibility

Ages Eligible for Study
18 - 79 Years

Genders Eligible for Study
Both

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

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