Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Intracranial Aneurysms
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: the Neuroform EZ Stent System was initially developed by SMART Therapeutics (San Leandro, CA, USA), with FDA HDE approval in 2002. This Stent system was later acquired by Boston Scientific, and then later acquired by Stryker Inc., Neurovascular Division. The Stent system was initially named the "Neuroform Microdelivery Stent System", and now has been re-branded as the "Neuroform EZ Stent System",Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is a prospective study to investigate the efficacy of using stent-assistance for embolization of intracranial aneurysms with a wide neck (defined as > or = to 4mm, or with a dome to neck ratio of 2:1 or less). We plan to investigate successful embolization of intracranial aneurysms defined by a...

This is a prospective study to investigate the efficacy of using stent-assistance for embolization of intracranial aneurysms with a wide neck (defined as > or = to 4mm, or with a dome to neck ratio of 2:1 or less). We plan to investigate successful embolization of intracranial aneurysms defined by angiographic occlusion of greater than or equal to 90% at 6 months. Patients will be followed for a minimum period of 2 years from the date of the procedure, with a planned total duration of 4 years of the study, including follow up time. Participants will be initially assessed and if included, will undergo procedure that includes use of the device. Afterwards, they will be scheduled for regular follow up at 2 weeks for clinical assessment, then again at 3 months for clinical assessment and MRA to investigate the stented region, then again at 6 months for clinical assessment and possible cerebral angiogram vs possible MRA, and then again at 1 year post-procedure, and then again at 2 years post-procedure. Patients may then follow up on an annual basis or every 2-3 years, depending on preference and any residual or recurrent aneurysm. A more specific timeline and treatment course is described below. Patients will receive cerebral angiography for evaluation of their cerebral vasculature and aneurysm configuration to ensure that the parent vessel diameter is adequate and that the aneurysm is 4mm in size with a wide neck. In these cases, if it is determined that the patient will require additional vascular support in order to adequately embolize the aneurysm then the use of stent-assisted coil embolization may be offered to the patient. Once enrolled, patients will undergo endovascular stent-assisted coil embolization of the aneurysm, and clinical outcomes will then be assessed. Data will be collected for analysis according to the primary and secondary outcome measures in addition to any deviations from the protocol or safety concerns as well

Tracking Information

NCT #
NCT04566263
Collaborators
Not Provided
Investigators
Principal Investigator: Bartley Mitchell, M.D. Methodist Brain and Spine Institute