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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT04271033
Eligibility Criteria:
General Inclusion Criteria:
* Patient \> 18 years old qualified by NeuroVascular Team for carotid revascularization according to local standards of care
* Signed informed consent
* Agreement (routin un this group of patients) to clinical and ultrasonographis follow up.
Angiographic Inclusion Criteria:
* De-novo atherosclerotic lesions or neo-atherosclerosis
* Symptomatic patients (history of transient ischemic attack, ischaemic stroke or amaurosis fugax within 6 months from index procedure) with index artery stenosis ≥50% assessed in angiography with NASCET method or
* Asymptomatic patients with index artery stenosis ≥70-80% assessed in angiography with NASCET method
General Exclusion Criteria:
* Lack of NeuroVascular Team agreement on carotid revascularization indication
* Lack of signed informed consent
* Estimated life expectancy less than 1 year
* Chronic renal failure with serum creatinine level \> 3.0 mg/dL
* Myocardial Infarction within 72 hours prior to index procedure.
* Pregnant women
* Diagnosed coagulopathies
* History of contrast media allergy, not reacting to pharmacotherapy
Angiographic Exclusion Criteria:
* Index lesion occlusion
* Common carotid artery stent protruding to aortic arch
* Anatomical conditions restricting stent implantation
* Significant common carotid artery stenosis proximal to index lesion (unless treated)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04271033
Study Brief:
Protocol Section:
NCT04271033