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

Ki vehet részt

• 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

Ki nem vehet részt

• Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region
• Subject is enrolled in another device or drug study in which participation could confound study results
• 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 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
• Subject has absent femoral pulses or other condition preventing femoral access, or is planned to be treated using a radial access approach
• 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
• 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 symptomatic extracranial or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm
• 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