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

Trial details

Who runs it

Microvention-Terumo, Inc.

Trial code

NCT05409989

Record updated

10 November 2026

Original description

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.Read full original descriptionShow less

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: 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: 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.

ClinicalTrials.gov NCT05409989