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 |
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
We found this trial at
64
sites
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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University of Louisville The University of Louisville is a state supported research university located in...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Pittsburgh, Pennsylvania 15232
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
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Springfield, Illinois 62701
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110 Irving St NW
Washington, District of Columbia 20010
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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