Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT02118233
Eligibility Criteria:
Inclusion Criteria:
* Patients with asymptomatic (defined as no symptoms in past 6 months) carotid stenosis
* Patients with hemodynamically significant carotid artery stenosis (according to CREST criteria: ≥ 60% by angiography, OR ≥ 70% by ultrasound, OR ≥ 80% by CTA or MRA)
Exclusion Criteria:
* Patients with prior large vessel infarct
* Patients with intracranial stenosis
* Patients with major depression
* Patients with Alzheimer disease (clinically defined or Wechsler IQ \<80)
* Patients who have had previous ipsilateral carotid surgery
* Patients with baseline dementia defined as: Mini-Mental Status Examination score \< 21 OR Mini-Mental score ≥21 AND Baseline HVLT scores more than 3 standard deviations below normal or FAS scores more than 2 standard deviations below normal OR other clinical symptoms that were not as evident on direct cognitive assessment (e.g. sundowning, getting lost while driving).
Note: A control group would be comprised of about 15 patients who meet eligibility criteria as above, but elect to have their condition followed rather than undergo revascularization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02118233
Study Brief:
Protocol Section:
NCT02118233