NCT04825080|Unknown
Carotid Asymptomatic Stenosis
CARAS
Natural History of Asymptomatic Carotid Artery Stenosis in the Modern Era
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CARAS
Natural History of Asymptomatic Carotid Artery Stenosis in the Modern Era
Sponsor study identifier
observational
300
1 country
1
Study Start
January 1, 2019
Actual (reported)Primary Completion
January 1, 2021
Actual (reported)Study Completion
January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
There is debate on the natural history of asymptomatic severe carotid artery stenosis. Previous studies conducted more than 20 years ago revealed the benefit of carotid endarterectomy compared with medical therapy only on the stroke prevention. However, today it seems that the current medical regimen can reduce the cerebral ischemic event rate in patients with asymptomatic severe carotid artery stenosis to less than 1% per year, making it questionable to choose the surgical treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)January 1, 2021
Actual (reported)March 26, 2021
Actual (reported)April 1, 2021
Actual (reported)January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Cerebral ischemic events
Stroke and transient cerebral ischemic events or amaurosis fugax, evaluated by clinical neurologist by clinical examination (National Institutes of Health Stroke Scale, NIHSS or modified Rankin scale, mRS)
5 years
Ipsilateral cerebral ischemic events
Ipsilateral stroke and transient cerebral ischemic events or amaurosis fugax, evaluated by clinical neurologist by clinical examination (National Institutes of Health Stroke Scale, NIHSS or modified Rankin scale, mRS)
5 years
Plaque progression
5 years
Patient's adherence to the medical therapy
5 years
Survival
5 years
Identification of carotid artery stenosis \> 60% NASCET criteria
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients are prospectively identified and enrolled in a single center vascular surgery ambulatory and a duplex ultrasonography (DUS) laboratory. Carotid artery stenosis are identified and the degree of stenosis \>60% is evaluated according to the current guidelines for stenosis identification through blood flow velocities. Patients enrollment goes from January 2019 to March 2020. The investigators prospectively complete the dedicated database including clinical characteristics, cardiovascular risk factors, medical therapy in use, features of the carotid plaque and contralateral carotid status.
Policlinico S. Orsola Malpighi
Bologna, 40138, Italy
First Submitted
March 26, 2021
First Posted
April 1, 2021
Study Start
January 1, 2019
Actual (reported)Primary Completion
January 1, 2021
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 1, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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