Clinical Trial: Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms - The CanFRED Trial
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.
Detailed Summary:
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Current Primary Outcome:
- death or major stroke [ Time Frame: within 30 days post procedure ]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. [ Time Frame: within 6 months post procedure ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of FRED System and procedure related Serious Adverse Events; [ Time Frame: 1 year ]
- Incidence of successful delivery of the FRED System implant; [ Time Frame: 24 hours ]
- Incidence of migration of the FRED System implant [ Time Frame: 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) [ Time Frame: Within 6 months ]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) [ Time Frame: 6 months ]as measured by an increase in the modified Rankin Scale compared to baseline
Original Secondary Outcome: Same as current
Information By: Centre hospitalier de l'Université de Montréal (CHUM)
Dates:
Date Received: December 3, 2014
Date Started:
Date Completion: September 2017
Last Updated: July 27, 2015
Last Verified: July 2015