Back to resultsMicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Primary Purpose
Intracranial Aneurysm
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FRED™ X™
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysm
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Sites / Locations
- Memorial Healthcare SystemsRecruiting
- Orlando HealthRecruiting
- University of IowaRecruiting
- Baptist Healthcare SystemRecruiting
- Massachusetts General BrighamRecruiting
- Albany Medical CenterRecruiting
- Montefiore Medical CenterRecruiting
- Northwell HealthRecruiting
- Ohio Health Riverside Research InstituteRecruiting
- Thomas Jefferson UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Flow Re-Direction Endoluminal Device X
Arm Description
FRED™ X™ device
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05409989
Brief Title
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Official Title
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
September 2029 (Anticipated)
Study Completion Date
November 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microvention-Terumo, Inc.
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Flow Re-Direction Endoluminal Device X
Arm Type
Other
Arm Description
FRED™ X™ device
Intervention Type
Device
Intervention Name(s)
FRED™ X™
Other Intervention Name(s)
Flow Re-Direction Endoluminal Device X
Intervention Description
The FRED™ X™ System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment.
Primary Outcome Measure Information:
Title
Primary Safety Endpoint Part 1: Proportion of subjects that experience either Death or major stroke within 30 days post-procedure.
Description
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.
Time Frame
30-days
Title
Primary Safety Endpoint Part 2: Proportion of subjects that experience neurological death or major ipsilateral stroke within 12 months post-procedure.
Description
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.
Time Frame
12 months
Title
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.
Description
(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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Bowles
Phone
678-858-0992
Email
Amy.bowles@microvention.com
Facility Information:
Facility Name
Memorial Healthcare Systems
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Gomez-Ramirez
Phone
954-265-6653
Email
agomezramirez@mhs.net
First Name & Middle Initial & Last Name & Degree
Haris Kamal, MD
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlene Carlo
Phone
407-739-0982
Email
charlene.carlo@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Jay Vachhani, MD
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heena Olade
Phone
319-356-8326
Email
heena-olalde@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Edgar Samaniego, MD
Facility Name
Baptist Healthcare System
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carry Doyle
Phone
502-896-3082
Email
Carry.doyle@BHSI.com
First Name & Middle Initial & Last Name & Degree
Richard Paulsen, MD
Facility Name
Massachusetts General Brigham
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel McLellan
Phone
617-726-3303
Email
rmclellan@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Robert Regenhardt, MD
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Paller
Phone
518-646-6761
Email
pallera@amc.edu
First Name & Middle Initial & Last Name & Degree
Alexandra Paul, MD
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genesis Liriano
Phone
718-920-2469
Email
gliriano@montefiore.org
First Name & Middle Initial & Last Name & Degree
David Altschul, MD
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Kozikowski
Phone
516-375-9053
Email
pkozikowski@northwell.edu
First Name & Middle Initial & Last Name & Degree
Henry Woo, MD
Facility Name
Ohio Health Riverside Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Bartelt
Phone
614-788-3863
Email
heather.bartelt@ohiohealth.com
First Name & Middle Initial & Last Name & Degree
Ronald Budzik, MD
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Kennedy
Phone
215-955-2173
Email
Tiffany.kennedy@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Nadirah Jones
Phone
215-955-7962
Email
nadirah.jones2@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Stavropoula Tjoumakaris, MD
12. IPD Sharing Statement
Learn more about this trial
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
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