Clinical trial NCT02309203: Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Intracranial Aneurysms
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: death or major stroke
timeFrame: within 30 days post procedure
measure: neurological death or major ipsilateral stroke, measured by mRS.
timeFrame: within 6 months post procedure
Secondary outcomes:
measure: Incidence of FRED System and procedure related Serious Adverse Events;
timeFrame: 1 year
measure: Incidence of successful delivery of the FRED System implant;
timeFrame: 24 hours
measure: Incidence of migration of the FRED System implant
timeFrame: 6 months
measure: 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)
timeFrame: Within 6 months
measure: Change in clinical and functional outcomes (as measured by an increase in the modified Rankin Scale compared to baseline)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: