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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT02398734
Eligibility Criteria:
Inclusion Criteria:
* Subject has a symptomatic or asymptomatic ICA stenosis ≥ 70 % (NASCET criteria) as detected by a duplex sonography (see Appendix) and confirmed using the computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA).
* Subject is indicated for CEA according to the criteria set by the American Heart Association.
* Subject is aged 40 - 85 years.
* Subject has a sufficient temporal bone window for TCD with detectable blood flow in the MCA.
* Subject is functionally independent with a modified Rankin score value of 0 - 2 points.
* Informed consent is signed by the subject.
Exclusion Criteria:
* Subject has been participating in another clinical trial within last 6 weeks.
* Subject has any other medical condition that would make him/her inappropriate for study participation, in the Investigator opinion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT02398734
Study Brief:
Protocol Section:
NCT02398734