Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization

Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization With the Stryker Neuroform EZ and Neuroform Atlas Stent Systems

This device was designed to assist in the stent-assisted coil embolization of intracranial aneurysms, specifically those that have a wide neck that would not otherwise maintain the coil embolization material within the aneurysm because of the wide opening at the base of the aneurysm. This device was designed to treat aneurysms that are: unruptured, wide-necked, intracranial, saccular aneurysms arising from a parent vessel ≥ 2 mm and ≤ 4.5 mm. Wide-necked was defined as having a neck > 4mm or dome-to-neck ratio < 2.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysms
• Intervention / Treatment: Device: Neuroform EZ Stent System

Detailed 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 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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients (18 years old or older) with intracranial aneurysms with a wide neck (defined as > or = to 4mm, or with a dome to neck ratio of 2:1 or greater).

Exclusion Criteria:

• Small-necked aneurysms,
• Inability to tolerate anti-platelet medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Successful embolization of intracranial aneurysms; Successful embolization of intracranial aneurysms defined by angiographic occlusion of greater than or equal to 90% at 6 months.	Device: Neuroform EZ Stent System; The Stryker Neuroform EZ Stent System is a self-expanding nitinol, compliant, open-cell design that can be deployed by a single operator. The Neuroform EZ Stent System is packaged sterile as a single unit with an introducer sheath and a detachable push wire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic occlusion	Successful embolization of intracranial aneurysms defined by angiographic occlusion of greater than or equal to 90%	6 months

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Bartley Mitchell, M.D., Methodist Brain and Spine Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): May 20, 2019
• Study Completion (Actual): January 7, 2021

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 002.VAS.2017.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes