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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT01340612
Eligibility Criteria:
Inclusion Criteria:
* All patients presenting at least one aneurysm candidate for coiling, with large (≥10mm), wide-necked (\>4mm), or recurrent lesions after coiling (but not stenting) and judged by the neurovascular team to require elective treatment provided that this single lesion, and no other aneurysm, will be treated during the endovascular session to be the object of the trial
* The anatomy of the lesion is such that endovascular treatment is judged possible with or without stenting
* The endovascular physician is a priori content to use either type of technique
* The patient has not previously been randomized into the trial
* Treatment is elective
* Patient is 18 or older
* Life expectancy is more than 2 years
* Patient has given fully informed consent and has signed consent form
Exclusion Criteria:
* Other aneurysms requiring treatment during the same session
* Patients with associated cerebral arteriovenous malformations
* Patients with recently ruptured aneurysms
* When parent vessel occlusion is the primary intent of the procedure
* Any absolute contraindication to endovascular treatment, angiography, or anesthesia such as severe allergies to contrast or medications, including ASA and Clopidogrel
* Patients with recurring, previously stented aneurysms
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01340612
Study Brief:
Protocol Section:
NCT01340612