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

April 18, 2024 updated by: Microvention-Terumo, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Healthcare Systems
        • Contact:
        • Principal Investigator:
          • Haris Kamal, MD
      • Orlando, Florida, United States, 32806
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Principal Investigator:
          • Edgar Samaniego, MD
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas
        • Principal Investigator:
          • Koji Ebersole, MD
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40241
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Baptist Healthcare System
        • Contact:
        • Principal Investigator:
          • Richard Paulsen, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Health
        • Contact:
        • Principal Investigator:
          • Gabriel Vidal, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Contact:
        • Principal Investigator:
          • Jacob Cherian, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Brigham Incorporated
        • Contact:
        • Principal Investigator:
          • Robert Regenhardt, MD
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Memorial Health
        • Principal Investigator:
          • Jasmeet Singh, MD
        • Contact:
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical Center
        • Contact:
        • Principal Investigator:
          • Alexandra Paul, MD
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • David Altschul, MD
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo
        • Principal Investigator:
          • Adnan Siddiqui, MD
        • Contact:
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Contact:
        • Principal Investigator:
          • Henry Woo, MD
      • Stony Brook, New York, United States, 11794
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Principal Investigator:
          • Patrick Youssef, MD
        • Contact:
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Ohio Health Riverside Research Institute
        • Contact:
        • Principal Investigator:
          • Ronald Budzik, MD
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • ProMedica Toledo Hospital
        • Principal Investigator:
          • Syed Zaidi, MD
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Principal Investigator:
          • Hakeem Shakir, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Principal Investigator:
          • Jan-Karl Burkhardt, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
        • Principal Investigator:
          • Stavropoula Tjoumakaris, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects for this study must meet ALL the following 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:

Subjects shall be excluded from the study if ANY of the following conditions exist:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Flow Re-Direction Endoluminal Device X
FRED™ X™ device
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.
Other Names:
  • Flow Re-Direction Endoluminal Device X

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint Part 1: Proportion of subjects that experience either Death or major stroke within 30 days post-procedure.
Time Frame: 30-days
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.
Time Frame: 12 months
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.
Time Frame: 12 months
(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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Microvention-Terumo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2022

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

June 4, 2022

First Submitted That Met QC Criteria

June 4, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL11023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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