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

Intracranial Aneurysms Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02309203
• Other study ID #: CE 14.295
• Status: Withdrawn
• Phase: N/A
• First received: December 3, 2014
• Last updated: July 27, 2015
• Est. completion date: September 2017

Study information

• Verified date: July 2015
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Device:
• FRED
Flow Re-Direction Endoluminal Device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	neurological death or major ipsilateral stroke, measured by mRS.		within 6 months post procedure	Yes
Secondary	Incidence of FRED System and procedure related Serious Adverse Events;		1 year	Yes
Secondary	Incidence of successful delivery of the FRED System implant;		24 hours	No
Secondary	Incidence of migration of the FRED System implant		6 months	Yes
Secondary	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	No
Secondary	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	Yes