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

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Withdrawn

Conditions

Intracranial Aneurysms

Treatments

Device: FRED

Study type

Interventional

Funder types

Other

Identifiers

NCT02309203

CE 14.295

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.