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

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

The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study.

Inclusion Criteria:

Subjects for this study must meet ALL the following criteria:

1. Subject has single target aneurysm in the internal carotid artery from petrous segment to the terminus of the internal carotid artery.
2. The parent artery diameter must be 2.0 - 5.0 mm distal and/or proximal to the target intracranial aneurysm.
3. Negative pregnancy test (serum or urine) in a female subject who has had menses in the last 18 months.
4. 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.
5. The subject or his/her authorized representative must sign the IRB-approved written informed consent form prior to the start of any study procedures.
6. The subject has a modified Rankin Scale (mRS) ≤ 2.
7. 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:

1. Subject who suffers from a subarachnoid hemorrhage in the last 60 days.
2. Subject who suffers from intracranial hemorrhage in the last 30 days.
3. Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
4. Subject with symptomatic extracranial or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm.
5. 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.
6. Subject with history of major bleeding disorder (based on coagulation profile and platelet count) and/or subject presents with signs of active bleeding.
7. Subject with known hypersensitivity to any component of the treatment device that cannot be medically controlled.
8. Subject with documented contrast allergy, or other condition that prohibits imaging.
9. Evidence of active bacterial infection at the time of treatment.
10. 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%.
11. Subject with a pre-existing stent in place at the target aneurysm.
12. Subject who is unable to complete the required follow-ups.
13. Subject who is pregnant, breastfeeding, or of childbearing potential and unwilling to prevent pregnancy during their participation in the study.
14. Subject has a serious or life-threatening comorbidity that could confound study results and/or prevent completion of 5-year followup.
15. Subject is enrolled in another device or drug study in which participation could confound study results.
16. Subject has absent femoral pulses or other condition preventing femoral access, or is planned to be treated using a radial access approach.