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 @ 3:26 PM
Ignite Modification Date:
2025-12-24 @ 3:26 PM
NCT ID:
NCT01139892
Eligibility Criteria:
Inclusion Criteria:
* Patients at least 18 years of age with at least 10 years of remaining life expectancy
* At least one documented, intradural, saccular intracranial aneurysm
* The patient and aneurysm are considered appropriate for either surgical or endovascular treatment by the treating team
* Aneurysm size 3-25 mm
Exclusion Criteria:
* Patients with any intracranial hemorrhage, including SAH, within the previous 30 days
* Lesion characteristics not readily suitable for either endovascular or surgical treatment, in the opinion of the physician(s) intending to treat the aneurysm
* Multiple aneurysms, where the treatment plan includes both surgical clipping as well as endovascular coiling
* Aneurysm anticipated (pre-operatively) to require proximal vessel occlusion, a bypass, or other flow-redirecting therapy (such as flow-diverting stents) as part of treatment plan
* Patients with baseline mRS \>2
* Patients with a single cavernous aneurysm
* Patients with dissecting, fusiform, or mycotic aneurysms
* Patients with AVM-associated aneurysms
* Pregnant patients (randomization (and treatment) may be delayed until after delivery)
* Patients with absolute contraindications to anaesthesia, endovascular treatment or administration of contrast material, including low-osmolarity agents or gadolinium
* Patients unable to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01139892
Study Brief:
Protocol Section:
NCT01139892