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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT04679727
Eligibility Criteria:
Inclusion Criteria:
* Asymptomatic carotid artery lesions between 40 and 60%, at carotid artery ultrasound, for which lesions an interventional strategy - beside optimal medical therapy - is not clearly defined.
* Patients with asymptomatic carotid artery stenosis higher than 60% will be enrolled when revascularization by either carotid endarterectomy (CEA) or stenting will be considered not indicated or not feasible
* Both genders (with capping implemented in order to ensure a 50±5% balance of males to females),
Exclusion Criteria:
* Severe comorbidities a priori precluding the 2-year follow-up (cachexia; end-stage cancer; severe renal/respiratory insufficiency; advanced (class IV) heart failure; atrial fibrillation and other significant arrhythmias).
* Severe allergic diathesis; contraindications to contrast agents for angio-TC or MRI; claustrophobia; presence of prostheses/implanted electronic devices not suitable for MRI; lack of consent for any reason.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT04679727
Study Brief:
Protocol Section:
NCT04679727