Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms (CanFRED)

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.

Study Overview

• Status: Withdrawn
• Conditions: Intracranial Aneurysms
• Intervention / Treatment: Device: FRED

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flow Re-Direction Endoluminal Device; Flow Re-Direction Endoluminal Device (FRED Device)	Device: FRED; Flow Re-Direction Endoluminal Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 30 days post procedure
neurological death or major ipsilateral stroke, measured by mRS.		within 6 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of FRED System and procedure related Serious Adverse Events;		1 year
Incidence of successful delivery of the FRED System implant;		24 hours
Incidence of migration of the FRED System implant		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	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	6 months

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimate): December 5, 2014

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CE 14.295