Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms (CanFRED)
Primary Purpose
Intracranial Aneurysms
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FRED
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysms
Eligibility Criteria
Inclusion Criteria:
- Subject whose age is ≥ 18 years;
- Subject has a single target aneurysm located in the following zones:
- Zone 1 - Petrous through cavernous of the ICA
- Zone 2 - Ophthalmic segment of the ICA
- Zone 3-Posterior Circulation, basilar artery (not including the basilar bifurcation), vertebral artery
- Subjects with a single target intracranial aneurysm located along the internal carotid artery, or the vertebral or basilar artery for whom existing endovascular options (coiling, stent-assisted-coiling) could be ineffective or because aneurysm is predisposed to recurrence due to having any of the following characteristics:
- Aneurysms with a neck > 4mm, dome to neck ratio ≤2 or no discernible neck
- Fusiform aneurysms of any size requiring treatment;
- The parent artery must have a diameter of 2.5 - 5.0mm distal/proximal to the target intracranial aneurysm (IA);
- Subject fulfills study requirements, and the subject or his/her legally authorized representative provides a signed informed consent form;
- Negative pregnancy test in a female subject who has had menses in the last 24 months;
- Subject is willing to return for the 1-month and 6-month follow-up evaluations
Exclusion Criteria:
- Subject who is pregnant or breastfeeding; Subject who suffers from a subarachnoid hemorrhage in the last 60 days;
- Subject who suffers from any intracranial hemorrhage in the last 30 days;
- Subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region;
- Subject with stenosis of the parent artery (>50%) proximal to the target aneurysm;
- Subject with known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents;
- Subject with contraindications or severe allergies to anticoagulants or antiplatelet medications (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor);
- Subject with known hypersensitivity to metal, such as nickel-titanium and metal jewelry
- Subject with documented contrast allergy, or other condition, that prohibits imaging.
- Evidence of active bacterial infection at the time of treatment;
- Subject who has had a previous intracranial stenting procedure associated with the target aneurysm;
- Subject with life-threatening diseases.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Flow Re-Direction Endoluminal Device
Arm Description
Flow Re-Direction Endoluminal Device (FRED Device)
Outcomes
Primary Outcome Measures
death or major stroke
A major stroke is defined as a new neurological event that persists for > 24 hours and results in a mRS >2. A minor stroke is defined as a new neurological event that persists for > 24 hours.
neurological death or major ipsilateral stroke, measured by mRS.
Secondary Outcome Measures
Incidence of FRED System and procedure related Serious Adverse Events;
Incidence of successful delivery of the FRED System implant;
Incidence of migration of the FRED System implant
Unplanned alternative treatment on the target IA (Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject)
Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject
Change in clinical and functional outcomes (as measured by an increase in the modified Rankin Scale compared to baseline)
as measured by an increase in the modified Rankin Scale compared to baseline
Full Information
NCT ID
NCT02309203
First Posted
December 3, 2014
Last Updated
July 27, 2015
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT02309203
Brief Title
Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms
Acronym
CanFRED
Official Title
Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms - The CanFRED Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study not initiated at our site.
Study Start Date
undefined (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study objective is to evaluate the safety and effectiveness of the MicroVention FRED System when used in the treatment of wide-necked intracranial aneurysms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flow Re-Direction Endoluminal Device
Arm Type
Experimental
Arm Description
Flow Re-Direction Endoluminal Device (FRED Device)
Intervention Type
Device
Intervention Name(s)
FRED
Intervention Description
Flow Re-Direction Endoluminal Device
Primary Outcome Measure Information:
Title
death or major stroke
Description
A major stroke is defined as a new neurological event that persists for > 24 hours and results in a mRS >2. A minor stroke is defined as a new neurological event that persists for > 24 hours.
Time Frame
within 30 days post procedure
Title
neurological death or major ipsilateral stroke, measured by mRS.
Time Frame
within 6 months post procedure
Secondary Outcome Measure Information:
Title
Incidence of FRED System and procedure related Serious Adverse Events;
Time Frame
1 year
Title
Incidence of successful delivery of the FRED System implant;
Time Frame
24 hours
Title
Incidence of migration of the FRED System implant
Time Frame
6 months
Title
Unplanned alternative treatment on the target IA (Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject)
Description
Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject
Time Frame
Within 6 months
Title
Change in clinical and functional outcomes (as measured by an increase in the modified Rankin Scale compared to baseline)
Description
as measured by an increase in the modified Rankin Scale compared to baseline
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject whose age is ≥ 18 years;
Subject has a single target aneurysm located in the following zones:
Zone 1 - Petrous through cavernous of the ICA
Zone 2 - Ophthalmic segment of the ICA
Zone 3-Posterior Circulation, basilar artery (not including the basilar bifurcation), vertebral artery
Subjects with a single target intracranial aneurysm located along the internal carotid artery, or the vertebral or basilar artery for whom existing endovascular options (coiling, stent-assisted-coiling) could be ineffective or because aneurysm is predisposed to recurrence due to having any of the following characteristics:
Aneurysms with a neck > 4mm, dome to neck ratio ≤2 or no discernible neck
Fusiform aneurysms of any size requiring treatment;
The parent artery must have a diameter of 2.5 - 5.0mm distal/proximal to the target intracranial aneurysm (IA);
Subject fulfills study requirements, and the subject or his/her legally authorized representative provides a signed informed consent form;
Negative pregnancy test in a female subject who has had menses in the last 24 months;
Subject is willing to return for the 1-month and 6-month follow-up evaluations
Exclusion Criteria:
Subject who is pregnant or breastfeeding; Subject who suffers from a subarachnoid hemorrhage in the last 60 days;
Subject who suffers from any intracranial hemorrhage in the last 30 days;
Subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region;
Subject with stenosis of the parent artery (>50%) proximal to the target aneurysm;
Subject with known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents;
Subject with contraindications or severe allergies to anticoagulants or antiplatelet medications (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor);
Subject with known hypersensitivity to metal, such as nickel-titanium and metal jewelry
Subject with documented contrast allergy, or other condition, that prohibits imaging.
Evidence of active bacterial infection at the time of treatment;
Subject who has had a previous intracranial stenting procedure associated with the target aneurysm;
Subject with life-threatening diseases.
12. IPD Sharing Statement
Learn more about this trial
Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms
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