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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT01945827
Eligibility Criteria:
Inclusion Criteria:
* Subject age ≥18 and ≤80 with a diagnosis of ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure
* Investigator intends to use DeltaMaxx Microcoil system during coiling procedure
* Investigator intends to use only Codman Neuro microcoils during coiling procedure
* Aneurysm size \[largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen\] ≥6 mm
* If ruptured aneurysm: Hunt and Hess 1, 2, or 3
* If unruptured aneurysm: Subject grade Modified Rankin Scale 0 - 2
* The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study and agree to return for all study visits.
Exclusion Criteria:
* Prior treatment (surgical or endovascular) of the target aneurysm
* Subjects with more than one aneurysm (\>2 mm) that have been treated with endovascular or clipping techniques in the past 30 days.
* Subject with social, medical or psychological conditions that interfere with treatment and follow-up evaluation
* Women who are pregnant or plan to become pregnant during the study
* Life expectancy less than 12 months.
* Presence of arteriovenous malformation
* Fusiform, mycotic, traumatic, or tumoral aneurysms
* Planned aneurysm treatment by parent vessel occlusion
* Subject enrolled in any concurrent study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01945827
Study Brief:
Protocol Section:
NCT01945827