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 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT03161769
Eligibility Criteria:
Inclusion Criteria:
1. Subject with unruptured, large (≥8mm) saccular aneurysm(s) located in the anterior intracranial circulation and suitable for an endovascular treatment with a Flow Diverter Stent.
2. Subject has signed an institutionally approved research informed consent form.
3. Subject ≥ 18 years old.
Exclusion Criteria:
1. Subject with non-saccular brain aneurysm (s) such as:- dissecting; fusiform; atherosclerotic; mycotic; bifurcational.
2. Subject underwent a prior target brain aneurysm treatment with either endovascular (stenting, coiling) or surgical (clipping) techniques.
3. The endovascular treatment of subject's target aneurysm(s) was assisted with coils or intracranial stents (non-FDS) before the AneurysmFlow calculations.
4. Subject with partially thrombosed or recanalized target brain aneurysm(s).
5. Subject had prior significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications.
6. Subject with severe kidney disease (e-GFR \< 60).
7. Subject is not willing (or not able) to attend post FDS insertion follow up clinic visits requiring DSA, head MRI or CTA imaging.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03161769
Study Brief:
Protocol Section:
NCT03161769