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

NCT02309203 | Withdrawn DMC

• 1 other identifier: CE 14.295
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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)

  Within 6 months

• Change in clinical and functional outcomes (as measured by an increase in the modified Rankin Scale compared to baseline)

  6 months

Study Arms (1)

Flow Re-Direction Endoluminal Device

EXPERIMENTAL

Flow Re-Direction Endoluminal Device (FRED Device)

Device: FRED

Interventions

FRED DEVICE

Flow Re-Direction Endoluminal Device

Flow Re-Direction Endoluminal Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Primary Completion: February 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 28, 2015

Record last verified: 2015-07