MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
NCT ID: NCT05409989
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
154 participants
INTERVENTIONAL
2022-09-20
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Flow Re-Direction Endoluminal Device X
FRED™ X™ device
FRED™ X™
The FRED™ X™ System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment.
Interventions
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FRED™ X™
The FRED™ X™ System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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.
22 Years
75 Years
ALL
No
Sponsors
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Microvention-Terumo, Inc.
INDUSTRY
Responsible Party
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Locations
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Memorial Healthcare Systems
Hollywood, Florida, United States
Orlando Health
Orlando, Florida, United States
Queen's Medical Center
Honolulu, Hawaii, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas
Kansas City, Kansas, United States
Baptist Healthcare System
Louisville, Kentucky, United States
Norton Healthcare
Louisville, Kentucky, United States
Ochsner Health
New Orleans, Louisiana, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Brigham Incorporated
Boston, Massachusetts, United States
UMass Memorial Health
Worcester, Massachusetts, United States
Albany Medical Center
Albany, New York, United States
University at Buffalo
Buffalo, New York, United States
Northwell Health
Manhasset, New York, United States
Mount Sinai
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Ohio State University
Columbus, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Houston Methodist Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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CL11023
Identifier Type: -
Identifier Source: org_study_id
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