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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT01550835
Eligibility Criteria:
Inclusion Criteria:
* ICA stenosis greater than 50 percent by carotid angiography
* Documented hemispheric ischemic stroke, TIA, amaurosis fugax, or retinal stroke in the last six months ipsilateral to the stented lesion
Exclusion Criteria:
* Subject less than 40 years of age
* Pregnant subjects
* Asymptomatic carotid stenosis
* Total occlusion of target carotid artery
* Inability to deploy distal protection device or stent in target vessel
* Allergy to both aspirin and approved thienopyridine anti-platelet drugs (clopidogrel/ticlopidine)
* Multiple carotid stenoses in same vessel that cannot be covered by single stent
* Ipsilateral intracranial stenosis requiring treatment
* Isolated common carotid stenosis
* Stenosis less than 50 percent by angiography
* Chronic or paroxysmal atrial fibrillation not treated with warfarin or dabigatran.
* Life expectancy less than 30 days
* Active bleeding diathesis
* Suspected Myocardial Infarction within 72 hours prior to carotid stenting
* Presence of intracranial tumor arteriovenous malformations or aneurysm requiring treatment
* Inability to undergo DWMRI
* Unwillingness to participate or provide consent
* Subjects using a legally authorized representative for consent for participation
* Concurrently enrolled in another study
* Stroke, TIA, amaurosis fugax ipsilateral to the treated lesion more than 6 months from randomization
* Occlusive or critical ilio-femoral disease that precludes safe femoral access to the aortic arch
* Severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries
* Prior large stroke, multiple lacunar infarcts, or dementia
* Stenosis that contain visible thrombus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01550835
Study Brief:
Protocol Section:
NCT01550835