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

NCT05409989 | Active Not Recruiting FDA Device

• 1 other identifier: CL11023
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 23

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 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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (3)

• Primary Safety Endpoint Part 1: Proportion of subjects that experience either Death or major stroke within 30 days post-procedure.

  Major stroke is defined as a new neurological event that persists for \>24 hours and results in a ≥4-point increase in the NIHSS score compared to baseline or compared to any subsequent lower score.

  30-days

• Primary Safety Endpoint Part 2: Proportion of subjects that experience neurological death or major ipsilateral stroke within 12 months post-procedure.

  A major ipsilateral stroke is defined as that occurring within the vascular distribution of the stented artery. Neurological death is defined as a death which has been adjudicated by an independent clinical events committee to have directly resulted from a neurologic cause.

  12 months

• Primary Effectiveness Endpoint: The percent of subjects with (1) complete (100%) occlusion of the target aneurysm and ≤50% stenosis of the parent artery at the target IA, and (2) in whom an alternative treatment of the target IA had not been performed.

  (1) Complete (100%) occlusion of the target aneurysm is assessed utilizing the Raymond-Roy Scale (Raymond Roy Class 1) and ≤50% stenosis of the parent artery at the target IA), and in whom an alternative treatment of the target IA had not been performed. The study will utilize independent Core Laboratory to adjudicate all angiographic outcomes, including aneurysm occlusion status and parent artery stenosis. (2) Alternative treatment is defined as re-treatment of the target aneurysm with an alternative treatment modality including open repair, endovascular placement of an additional stent or treatment of in-stent stenosis.

  12 months

Study Arms (1)

Flow Re-Direction Endoluminal Device X

OTHER

FRED™ X™ device

Device: FRED™ X™

Interventions

FRED™ X™ DEVICE

The FRED™ X™ System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment.

Also known as: Flow Re-Direction Endoluminal Device X

Flow Re-Direction Endoluminal Device X

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Study Sites (23)

Memorial Healthcare Systems

Hollywood, Florida, 33021, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Baptist Healthcare System

Louisville, Kentucky, 40207, United States

Location

Norton Healthcare

Louisville, Kentucky, 40241, United States

Location

Ochsner Health

New Orleans, Louisiana, 70121, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Brigham Incorporated

Boston, Massachusetts, 02114, United States

Location

UMass Memorial Health

Worcester, Massachusetts, 01655, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2022
• First Posted: June 8, 2022
• Study Start: September 20, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): May 1, 2030
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (23)