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

NCT ID: NCT02309203

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2017-09-30

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.

Conditions

Intracranial Aneurysms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flow Re-Direction Endoluminal Device

Flow Re-Direction Endoluminal Device (FRED Device)

Group Type: EXPERIMENTAL

FRED

Intervention Type: DEVICE

Flow Re-Direction Endoluminal Device

Interventions

FRED

Flow Re-Direction Endoluminal Device

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Jean Raymond

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CE 14.295

Identifier Type: -

Identifier Source: org_study_id