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) "ACT I"

Terminated

Phase 3 Results

Update History

23 Oct '14
Trial name was updated.
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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)
20 Feb '13
A location was updated in Phoenix.
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The overall status was removed for St. Luke's Hospital-Phoenix.
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The overall status was removed for Mayo Clinic.
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The overall status was removed for University of Pittsburgh Physicians Division of Vascular Surgery/Shadyside Medical.
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The overall status was removed for The Stern Cardiovascular Center/Methodist Germantown Hospital.
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The overall status was removed for St. Luke's Medical Center - Milwaukee.
11 Feb '12
The Summary of Purpose was updated.
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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.
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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.
The description was updated.
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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.
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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.
A location was updated in Phoenix.
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The overall status was removed for Mayo Clinic.
A location was updated in Philadelphia.
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The overall status was removed for Hospital of the University of Pennsylvania.