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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT00766493
Eligibility Criteria:
Inclusion Criteria:
1. Subject is either:
* Symptomatic (amaurosis fugax in the hemisphere supplied by the target vessel, TIA or non-disabling stroke within 6 months of the procedure) with carotid stenosis ≥50% as diagnosed by angiography using NASCET methodology, OR
* Asymptomatic with carotid stenosis ≥80% as diagnosed by angiography using NASCET methodology
2. Target lesion is located in one of the following:
* ICA
* bifurcation
* CCA proximal to the bifurcation
3. At Anatomic risk for adverse events from CEA (e.g., restenosis after a prior CEA) or at Co-morbid risk for adverse events from CEA (e.g., unstable angina with ECG changes)
Exclusion Criteria:
* Recent surgical procedure within 30 days before or after the stent procedure
* Uncontrolled sensitivity to contrast media
* Renal Insufficiency
* Recent evolving, acute stroke within 21 days of study evaluation
* Myocardial infarction within 72 hours prior to stent procedure
* History of a prior major ipsilateral stroke with residual neurological deficits likely to confound the neurological assessments (e.g., NIHSS)
* Neurological deficits not due to stroke likely to confound the neurological assessments (e.g., NIHSS)
Angiographic Exclusion Criteria:
* Isolated ipsilateral hemisphere leading to subject intolerance to reverse flow
* Total occlusion of the ipsilateral carotid artery
* Pre-existing stent in the ipsilateral carotid artery OR the contralateral carotid artery that extends into the aortic arch
* Presence of a filling defect, thrombus, occlusion or "string sign" in the target vessel
* Severe lesion calcification restricting stent deployment
* Carotid stenosis located distal to target stenosis that is more severe than target stenosis
* \>50% stenosis of the CCA proximal to target vessel
* Known mobile plaque in the aortic arch
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00766493
Study Brief:
Protocol Section:
NCT00766493