About this trial
The majority (\>80%) of strokes are of ischemic etiology, of which ≈15% to 20% are attributable to atherosclerosis of the extracranial carotid arteries. The primary goal in carotid artery revascularization is to prevent stroke in patients with carotid artery stenosis. Treatment options including carotid endarterectomy (CEA) and carotid artery stenting (CAS). Hence, the investigators aim to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in terms of long-term prognostic endpoints. Also, CEA and CAS result in different postoperative geometric features of carotid arteries that entail relevant modifications of rheological parameters, that may be associated with the risk of local complications and carotid artery restenosis. Finally, long-term and sustained cognitive benefits after carotid artery revascularization need further research and evidence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adult, Older Adult
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in cognitive score
Among those with flow failure (PWI "time to peak" (TTP) delay\>2 sec) and cognitive impairment (\>1.0 SD below age-matched norms) at baseline, cognitive change at 1 year will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.
Change in carotid stenosis
The stenosis of the carotid artery measured by contrast-enhanced CT will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.
Change in wall shear stress(WSS)
The hemodynamics factors: wall shear stress (WSS) at 1 year will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.
Change in oscillatory shear index (OSI)
The hemodynamics factors: oscillatory shear index (OSI) at 1 year will be compared between those receiving revascularization (CEA or CAS) versus those receiving IMM alone.
Secondary outcomes
Silent infarcts
MRI-determined silent infarcts present at 1 year that were not present at baseline, comparing by treatment group
White matter hyperintensity (WMH) volume
change in confluent white matter hyperintensity volume at 1 year, comparing by treatment group
Major adverse cardiovascular events
The major adverse cardiovascular events at 1 year, comparing by treatment group
The mortality rate
The mortality rate at 1 year, comparing by treatment group
Sponsors and contacts
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