Aneurysm Treatment Using Intrasaccular Flow Diversion With the ARTISSE™ Device (ARTISSE)

This is an interventional treatment trial for Intracranial Aneurysm Read More

Inclusion Criteria:

• Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
• Subject is at least 22 years old at the time of consent.
• Subject has a ruptured or unruptured, wide neck, bifurcating saccular intracranial aneurysm (IA) requiring endovascular treatment.

Exclusion Criteria:

• Subject has more than one aneurysm requiring treatment.
• Subject underwent treatment of another aneurysm inside the affected territory of the target aneurysm.
• Aneurysm is partially thrombosed.
• Aneurysm has been previously treated with surgery or endovascular therapy, or there is a stent or other obstruction in the parent artery at the target aneurysm location.
• Subject has had subarachnoid hemorrhage (SAH) from non target aneurysm or any other intracranial hemorrhage within 90 days prior to study procedure.
• Subject vessel has characteristics that preclude safe endovascular access.
• Subject has active vasospasm, malignant brain tumor or vascular malformation (e.g. arteriovascular malformation).
• Subject has had major surgery including endovascular procedures within the past 30 days prior to study procedure.
• Subject has a life expectancy of < 12 months.
• The Investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, conditions that may increase the chance of stroke) may be compromised by the subject's enrollment.
• Subject is pregnant or wishes to become pregnant during the length of study participation.
• Subject is participating in another clinical trial at any time during the duration of the study that could confound the treatment or outcomes of this investigation. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from Medtronic.