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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT02309203
Eligibility Criteria:
Inclusion Criteria:
* Subject whose age is ≥ 18 years;
* Subject has a single target aneurysm located in the following zones:
* Zone 1 - Petrous through cavernous of the ICA
* Zone 2 - Ophthalmic segment of the ICA
* Zone 3-Posterior Circulation, basilar artery (not including the basilar bifurcation), vertebral artery
* Subjects with a single target intracranial aneurysm located along the internal carotid artery, or the vertebral or basilar artery for whom existing endovascular options (coiling, stent-assisted-coiling) could be ineffective or because aneurysm is predisposed to recurrence due to having any of the following characteristics:
* Aneurysms with a neck \> 4mm, dome to neck ratio ≤2 or no discernible neck
* Fusiform aneurysms of any size requiring treatment;
* The parent artery must have a diameter of 2.5 - 5.0mm distal/proximal to the target intracranial aneurysm (IA);
* Subject fulfills study requirements, and the subject or his/her legally authorized representative provides a signed informed consent form;
* Negative pregnancy test in a female subject who has had menses in the last 24 months;
* Subject is willing to return for the 1-month and 6-month follow-up evaluations
Exclusion Criteria:
* Subject who is pregnant or breastfeeding; Subject who suffers from a subarachnoid hemorrhage in the last 60 days;
* Subject who suffers from any intracranial hemorrhage in the last 30 days;
* Subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region;
* Subject with stenosis of the parent artery (\>50%) proximal to the target aneurysm;
* Subject with known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents;
* Subject with contraindications or severe allergies to anticoagulants or antiplatelet medications (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor);
* Subject with known hypersensitivity to metal, such as nickel-titanium and metal jewelry
* Subject with documented contrast allergy, or other condition, that prohibits imaging.
* Evidence of active bacterial infection at the time of treatment;
* Subject who has had a previous intracranial stenting procedure associated with the target aneurysm;
* Subject with life-threatening diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02309203
Study Brief:
Protocol Section:
NCT02309203