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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT03663257
Eligibility Criteria:
Inclusion Criteria:
* Subject with unruptured, ≥5mm saccular aneurysm(s) located in the anterior intracranial circulation and suitable for an endovascular treatment with a Flow Diverter Stent
* Subject is 18 years of age or older, or of legal age to give informed consent per state or national law.
* Subject is available for clinical follow-ups.
Exclusion Criteria:
* Non-saccular brain aneurysm(s) (i.e. dissecting, fusiform, atherosclerotic, mycotic, bifurcational). Prior aneurysm treatment with either endovascular (stenting, coiling) or surgical (clipping) techniques.
* Endovascular treatment assisted with coils or intracranial stents
* Significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications.
* Severe kidney disease (Glomerular Filtration Rate \< 60).
* Subjects not willing (or able) to attend post FDS insertion standard-of-care follow up clinic visits requiring DSA, head MRI or CTA imaging.
* Subject participates in a potentially confounding drug or device trial during the course of the study.
* Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03663257
Study Brief:
Protocol Section:
NCT03663257