Status:
ACTIVE_NOT_RECRUITING
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Lead Sponsor:
Microvention-Terumo, Inc.
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief Summary
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 d...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
September 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT05409989
Start Date
September 20 2022
End Date
November 1 2029
Last Update
April 13 2025
Active Locations (25)
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1
Memorial Healthcare Systems
Hollywood, Florida, United States, 33021
2
Orlando Health
Orlando, Florida, United States, 32806
3
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
4
University of Iowa
Iowa City, Iowa, United States, 52242