Study:
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)
Rationale:
n/a
Purpose:
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.
Study Status: Terminated
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Carotid Artery Disease Carotid Stenosis Stroke Atherosclerosis |
Device: Carotid artery stenting with filter (interventional) Procedure: Carotid artery endarterectomy (surgical) |
Phase 3 |
Verified by
Abbott Vascular
April, 2013
Sponsored by: Abbott Vascular
Information provided by: Abbott Vascular
ClinicalTrials.gov identifier: NCT00106938
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Jon Matsumura, MD., Principal Investigator
Kenneth Rosenfield, MD., Principal Investigator