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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT03920358
Eligibility Criteria:
Inclusion Criteria:
1. Patient older than 18 years old
2. Patient harboring a non-acutely ruptured intracranial aneurysm within the last 30 days of presentation:
* for which use of FRED, FRED Jr or FRED X has been deemed appropriate
* being the only aneurysm to require treatment within the next 12 months
* and optionally previously treated by surgery (clipping) or with an intrasaccular device: aneurysm recanalized
3. Patient with a modified Rankin Scale (mRS) ≤ 2
4. Patient has received information about data collection and has signed and dated an Informed Consent Form
Exclusion Criteria:
1. Patient has suffered from an ICH within the 30 days prior to the procedure.
2. The aneurysm to be treated is associated with a cAVM
3. The aneurysm to be treated is in the posterior circulation
4. The aneurysm to be treated has a stenosis of its parent artery \>50%
5. Patient has another aneurysm previously treated with a stent or a flow diverter
* on the same parent vessel at any time
* on a different parent vessel, less than 3 months prior to the procedure (previously-implanted stents in the non-index proximal carotid are acceptable)
6. Patient with whom anticoagulant, antiplatelet or thrombolytic drugs are contra-indicated or test performed regarding AP medication administered is not efficient for the patient
7. Patient with known hypersensitivity to contrast products or nickel titanium, not treatable
8. Pregnancy or child breastfeeding
9. Patient unable or unlikely to complete required follow up
10. Patient has severe or fatal comorbidity or a life expectancy of less than 1 year
11. Treatment with a flow diverter other than FRED/ FRED Jr/ FRED X or in addition to FRED/ FRED Jr/ FRED X is planned
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03920358
Study Brief:
Protocol Section:
NCT03920358