International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach

Who can take part

• Subject has an intracranial aneurysm that can be treated with one of the proposed devices
• Subject age is ≥ 18 years
• Subject or subject's legally authorized representative (LAR) has signed written informed consent
• Subject is willing to comply with scheduled visits and examinations per institutional standard of care

Who cannot take part

• Subject is currently enrolled in or plans to be enrolled in a concurrent drug or device study
• Subject has a non-target aneurysm treated within 30 days prior to study enrollment
• Subject target aneurysm is a ruptured intracranial aneurysm (unless ruptured at least 21 days prior the day of the index procedure)
• Antiplatelet and/or anticoagulation therapy (e.g., aspirin and clopidogrel) is contraindicated for the subject
• Intracranial vasospasm not responsive to medical therapy; Additional Key Exclusion Criteria (Evolve EU only):
• Subject has a non-target aneurysm treated within 30 days prior to study enrollment
• Subject has undergone previous stent assisted coiling or flow diverter treatment of a parent artery aneurysm near the location of the target aneurysm
• Subject has a condition which will not allow him/her to comply with his/her post-procedure follow up per the institutional standard of care (medical condition, subject living abroad and unable to return for follow-up, e.g.)
• Subject has an active bacterial or viral infection
• The angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as:
• Subject has not received dual anti-platelet agents prior to the procedure or equivalent in accordance with standard medical practice
• Subject is pregnant or plans to become pregnant her study participation*
• Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study
• Subject has a target aneurysm other than saccular or fusiform intracranial aneurysms; e.g.: vertebrobasilar dolichoectasia (VBD)
• The parent vessel size does not fall within the indicated range defined by IFU
• Severe intracranial vessel tortuosity or stenosis; and/or
• Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study
• Subject has a modified Rankin Score (mRS) ≥3 at pre-procedure examination