" Endarterectomy Combined With Optimal Medical Therapy (OMT) vs OMT Alone in Patients With Asymptomatic Severe Atherosclerotic Carotid Artery Stenosis at Higher-than-average Risk of Ipsilateral Stroke "
NCT02841098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2024-07-11
Summary
The purpose of this study is to determine whether carotid surgery combined with optimal medical therapy improves long-term survival free of ipsilateral stroke in patients with asymptomatic carotid stenosis at higher-than-average risk of ipsilateral stroke when compared with optimal medical therapy alone.
Conditions
- Asymptomatic Carotid Artery Stenosis
Interventions
- OTHER
-
Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT)
Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT) (Surgery and Drug)
- DRUG
-
Optimal medical therapy alone
Optimal medical therapy alone
Sponsors & Collaborators
-
Hôpitaux Universitaires Paris Ile-de-Franc Ouest
collaborator OTHER -
Centre Hospitalier St Anne
lead OTHER
Principal Investigators
-
Jean-Louis MAS · CHSA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-16
- Primary Completion
- 2022-01-13
- Completion
- 2022-01-13
Countries
- France
Study Locations
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