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

Running, not enrolling · Not applicable

Conditions studied: Intracranial Aneurysm

In brief

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.

Key facts

Study ID: NCT05409989
Run by: Microvention-Terumo, Inc.
People needed: 154
Starts: 2022-09-20
Expected to finish: 2030-05-01
Last updated by the study team: 2026-03-24

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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

Full record on ClinicalTrials.gov

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