Carotid Stenting vs. Surgery of Severe Carotid Artery Disease and Stroke Prevention in Asymptomatic Patients (ACT I)



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:April 2005
End Date:December 2019
Contact:Leah Green
Email:leah.green@av.abbott.com
Phone:408-845-3000

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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)


The study is being conducted to demonstrate the non-inferiority of carotid artery stenting
(CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to
carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid
atherosclerotic disease.


Randomization for ACT 1 employs a 3:1 ratio of CAS versus CEA. A lead-in phase of up to 400
carotid stent subjects will provide investigators experience with the study devices prior to
pivotal enrollment.

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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