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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT04434456
Eligibility Criteria:
General
Inclusion Criteria:
* Patients older than 18 years, eligible for endovascular carotid artery aneurysm treatment with Micronet covered stent per Vascular Team evaluation, according to local standards
* Written, informed consent to participate
* Agreement to attend protocol required (standard) follow up visits and examinations
Exclusion Criteria:
* Preferred treatment other than stenting (surgery or conservative treatment / observation) per Vascular Team evaluation
* Life expectancy \<1 year (e.g. active neoplastic disease).
* Chronic kidney disease with creatinine \> 3.0 mg/dL.
* Myocardial infarction in 72 hours proceeding the stenting procedure (if possible, postponing the procedure)
* Pregnancy (positive pregnancy test)
* Coagulopathy.
* History of uncontrolled contrast media intolerance
Angiographic
Inclusion Criteria:
* Carotid artery aneurysm confirmed on angiography - symptomatic, dissected or enlarging
* Aneurysm eligible for endovascular treatment per Vascular Team evaluation (according to current standards, guidelines and study center practice)
Exclusion Criteria:
* Unsuccessful true lumen engagement
* Aneurysm neck anatomy precluding healthy-to-healthy coverage with stent
* Anatomic variants precluding stent implantation
* Mobile (free-floating) plaque elements in aorta or arteries proximal to target lesion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04434456
Study Brief:
Protocol Section:
NCT04434456