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

NCT04566263 | Completed FDA Device

• 1 other identifier: 002.VAS.2017.D
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Aneurysms

Outcome Measures

Primary Outcomes (1)

• Angiographic occlusion

  Successful embolization of intracranial aneurysms defined by angiographic occlusion of greater than or equal to 90%

  6 months

Study Arms (1)

Successful embolization of intracranial aneurysms

OTHER

Successful embolization of intracranial aneurysms defined by angiographic occlusion of greater than or equal to 90% at 6 months.

Device: Neuroform EZ Stent System

Interventions

Neuroform EZ Stent System DEVICE

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.

Successful embolization of intracranial aneurysms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bartley Mitchell, M.D.

  Methodist Brain and Spine Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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",

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: February 28, 2017
• Primary Completion: May 20, 2019
• Study Completion: January 7, 2021
• Last Updated: March 23, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)