Intracranial AneurysmsCanFREDNCT02309203
Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms
A study testing FRED in people with Intracranial Aneurysms, run by Centre hospitalier de l'Université de Montréal (CHUM).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- FRED
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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);
Show all 11Show fewer
- 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.
About this study
Official title: Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms - The CanFRED Trial
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.
- Conditions
- Intracranial Aneurysms
- Being tested
- FRED
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FREDDevice
Flow Re-Direction Endoluminal Device
| Study group | Role | What they receive |
|---|---|---|
| Flow Re-Direction Endoluminal Device | Experimental | Flow Re-Direction Endoluminal Device (FRED Device) Receives: Device: FRED |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 days post procedure
neurological death or major ipsilateral stroke, measured by mRS.
Measured: within 6 months post procedure
Secondary outcomes (5)
Incidence of FRED System and procedure related Serious Adverse Events;
Measured: 1 year
Incidence of successful delivery of the FRED System implant;
Measured: 24 hours
Incidence of migration of the FRED System implant
Measured: 6 months
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
Measured: Within 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Primary completionFeb 2017 (estimated)
- Study completionSep 2017 (estimated)
Why it stopped: Study not initiated at our site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Raymond, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309203
- Sponsor's protocol ID
- CE 14.295
- Acronym
- CanFRED
- Status last verified
- Jul 2015
- First submitted
- 3 Dec 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms - The CanFRED Trial
- ClinicalTrials.gov ID
- NCT02309203
- Acronym / sponsor ID
- CanFRED / CE 14.295
- Conditions
- Intracranial Aneurysms
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not initiated at our site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flow Re-Direction Endoluminal Device | Experimental | Device: FREDFlow Re-Direction Endoluminal Device (FRED Device) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FREDFlow Re-Direction Endoluminal Device | Device | Flow Re-Direction Endoluminal Device |
Primary outcome
death or major stroke
Time frame: within 30 days post procedure
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.
Time frame: within 6 months post procedure
5 secondary outcomes
Incidence of FRED System and procedure related Serious Adverse Events;
Time frame: 1 year
Incidence of successful delivery of the FRED System implant;
Time frame: 24 hours
Incidence of migration of the FRED System implant
Time frame: 6 months
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)
Time frame: Within 6 months
Change in clinical and functional outcomes (as measured by an increase in the modified Rankin Scale compared to baseline)
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
Related trials for Intracranial Aneurysms
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing FRED in people with Intracranial Aneurysms, run by Centre hospitalier de l'Université de Montréal (CHUM).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death or major stroke (time frame: within 30 days post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.