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:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT00830232
Eligibility Criteria:
Inclusion Criteria:
* Subject is at high risk for carotid endarterectomy due to either anatomic or co-morbid conditions; AND
* Symptomatic patients (TIA or non-disabling stroke within 6 months of the procedure), with carotid stenosis ≥ 50% as diagnosed by angiography, using NASCET methodology (50); OR
* Asymptomatic patients with carotid stenosis ≥ 80% as diagnosed by angiography, using NASCET methodology
Exclusion Criteria:
* Conditions that interfere with the evaluation of endpoints
* Subject has anticipated or potential sources of cardiac emboli
* Subject plans to have a major surgical procedure within 30 days after the index procedure.
* Subject has intracranial pathology that makes the subject inappropriate for study participation.
* Subject has a total occlusion of the ipsilateral carotid artery (i.e., CCA).
* Severe circumferential lesion calcification that may restrict the full deployment of the carotid stent.
* Carotid stenosis located distal to the target stenosis that is more severe than the target stenosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00830232
Study Brief:
Protocol Section:
NCT00830232