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

Primary Purpose

Intracranial Aneurysms

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

FRED

About this trial

This is an interventional treatment trial for Intracranial Aneurysms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Flow Re-Direction Endoluminal Device

Arm Description

Flow Re-Direction Endoluminal Device (FRED Device)

Outcomes

Primary Outcome Measures

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.

neurological death or major ipsilateral stroke, measured by mRS.

Secondary Outcome Measures

Incidence of FRED System and procedure related Serious Adverse Events;

Incidence of successful delivery of the FRED System implant;

Incidence of migration of the FRED System implant

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

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

Full Information

NCT ID

NCT02309203

First Posted

December 3, 2014

Last Updated

July 27, 2015

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

1. Study Identification

Unique Protocol Identification Number

NCT02309203

Brief Title

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

Acronym

CanFRED

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

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Study not initiated at our site.

Study Start Date

undefined (undefined)

Primary Completion Date

February 2017 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Aneurysms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flow Re-Direction Endoluminal Device

Arm Type

Experimental

Arm Description

Flow Re-Direction Endoluminal Device (FRED Device)

Intervention Type

Device

Intervention Name(s)

FRED

Intervention Description

Flow Re-Direction Endoluminal Device

Primary Outcome Measure Information:

Title

death or major stroke

Description

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.

Time Frame

within 30 days post procedure

Title

neurological death or major ipsilateral stroke, measured by mRS.

Time Frame

within 6 months post procedure

Secondary Outcome Measure Information:

Title

Incidence of FRED System and procedure related Serious Adverse Events;

Time Frame

1 year

Title

Incidence of successful delivery of the FRED System implant;

Time Frame

24 hours

Title

Incidence of migration of the FRED System implant

Time Frame

6 months

Title

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)

Description

Defined as re-treatment of the target aneurysm due to worsening of the clinical condition of the subject

Time Frame

Within 6 months

Title

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

Description

as measured by an increase in the modified Rankin Scale compared to baseline

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Learn more about this trial

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

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