Status:
COMPLETED
Comparing Carotid Stenting With Endarterectomy in Severe Asymptomatic Carotid Stenosis
Lead Sponsor:
Carmel Medical Center
Conditions:
Carotid Stenosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Purpose of this study: Primary: • Comparison of cardiovascular mortality and morbidity which includes cardiac and neurological morbidity (TIA and CVA) in the two invasive treatments of asymptomatic ...
Detailed Description
Background: the surgical treatment of severe carotid artery stenosis (\>70%) has been proven effective in prevention of cerebral vascular events in asymptomatic patients as compared with non invasive ...
Eligibility Criteria
Inclusion
- Stenosis of 70% or more by carotid artery duplex, CTA or MRA.
- No evidence of TIA or CVA originating in area of the brain supplied by the carotid artery under study, in the four months preceding treatment.
- Eligibility for both treatment options:
- suited for operative treatment as assessed by an anesthesiologist
- suited for endovascular procedure by established radiological guidelines (including: access to the stenotic area via the vessels of the aortic arch, the absence of occlusion preventing this access, absence of significant atherosclerosis within the arch of aorta, absence of torturous anatomy of the common and internal carotid artery, and absence of thrombus in the area of stenosis)
Exclusion
- \-
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00772278
Start Date
January 1 2009
End Date
September 1 2015
Last Update
July 25 2017
Active Locations (1)
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1
Carmel Medical Center
Haifa, Israel, 34362