MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study

Inclusion criteria

Subjects for this study must meet ALL the following criteria:

• Subject has single target aneurysm in the internal carotid artery from petrous segment to the terminus of the internal carotid artery.
• The parent artery diameter must be 2.0 - 5.0 mm distal and/or proximal to the target intracranial aneurysm.
• Negative pregnancy test (serum or urine) in a female subject who has had menses in the last 18 months.
• Subject commits to return to the investigational site for the 30- day, 6-month, 12-month, 2-year, 3-year, and 5-year follow-up evaluations.
• The subject or his/her authorized representative must sign the IRB-approved written informed consent form prior to the start of any study procedures.
• The subject has a modified Rankin Scale (mRS) ≤ 2.
• The subject has a wide-necked ( ≥4mm or dome-to-neck ratio <2) saccular or fusiform aneurysm.

Exclusion criteria

Subjects shall be excluded from the study if ANY of the following conditions exist:

• Subject who suffers from a subarachnoid hemorrhage in the last 60 days.
• Subject who suffers from intracranial hemorrhage in the last 30 days.
• Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
• Subject with symptomatic extracranial or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm.
• Subject with an irreversible bleeding disorder, a platelet count < 100 x 103 cells/mm3 or known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents or thrombolytic drugs.
• Subject with history of major bleeding disorder (based on coagulation profile and platelet count) and/or subject presents with signs of active bleeding.
• Subject with known hypersensitivity to any component of the treatment device that cannot be medically controlled.
• Subject with documented contrast allergy, or other condition that prohibits imaging.
• Evidence of active bacterial infection at the time of treatment.
• Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%.
• Subject with a pre-existing stent in place at the target aneurysm.
• Subject who is unable to complete the required follow-ups.
• Subject who is pregnant, breastfeeding, or of childbearing potential and unwilling to prevent pregnancy during their participation in the study.
• Subject has a serious or life-threatening comorbidity that could confound study results and/or prevent completion of 5-year followup.
• Subject is enrolled in another device or drug study in which participation could confound study results.
• Subject has absent femoral pulses or other condition preventing femoral access, or is planned to be treated using a radial access approach.