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Completed

NCT Number: NCT05254067

Enterprise 2 Vascular Reconstruction Device

The primary objective of this study is to collect data regarding the effectiveness of using the Enterprise 2 Reconstruction Device in successfully embolizing intracranial aneurysms with wide neck configuration.

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Key information

Conditions

Aneurysm Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moody Brain and Spine Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

The Codman Enterprise 2 Vascular Reconstruction Device is a self-expanding nitinol, compliant, closed-cell, recapturable design that can be deployed by a single operator. The Codman Enterprise 2 Vascular Reconstruction Device is packaged sterile as a single unit with an introducer sheath and a detachable push wire.

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. The Codman Enterprise 2 Vascular Reconstruction Device is approved by the FDA as a Humanitarian Use Device (HUD) in cases of wide-necked saccular cerebral aneurysms.

The primary objective of this study is to collect data regarding the effectiveness of using the Enterprise 2 Reconstruction Device in successfully embolizing intracranial aneurysms with wide neck configuration. Secondly, to determine any safety or delivery problems that may occur, or any adverse patient events that may have previously been undocumented.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, inappropriate for stenting.
  • Inability to tolerate anti-platelet medication.

Treatment and study plan

Codman Enterprise 2 Vascular Reconstruction Device

Device

a self-expanding nitinol, compliant, closed-cell, recapturable design that can be deployed by a single operator 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.

Primary outcomes

  1. Device Effectiveness-Stent Migration

    Time frame: Patients will be followed for a minimum period of 2 years from the date of the procedure, with planned total duration of 4 years of the study, including follow-up time.

    Prior Observation studies have noted in other stents, that over time, a stent may migrate from its original location, given the flow dynamics and potentially from stent under-sizing. This could potentially disrupt flow through the artery, or even uncover the aneurysm, openining, potentially allowing outflow of embolization coils.

  2. Device Effectiveness- Stent Fore-shortening

    Time frame: Patients will be followed for a minimum period of 2 years from the date of the procedure, with planned total duration of 4 years of the study, including follow-up time.

    If a stent contracts slightly after placement, then it could shorten slightly, particularly if the stent is placed around a tortous corner. In this type of event, generally there is no significant impact to the patient, unless the stent were to shorten and uncover the opening of the aneurysm, potentially allowing embolization coils to come out of the aneurysm.

  3. Device Effectiveness- In-stent stenosis

    Time frame: Patients will be followed for a minimum period of 2 years from the date of the procedure, with planned total duration of 4 years of the study, including follow-up time.

    In this known phenomenon with stents, it is possible that either through local inflammatory reaction or by hyper neointimalization, there can be a buildup of materila on the inner lumen of any stent that is placed.

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Official study title

Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization With the Codman Enterprise 2 Vascular Reconstruction Device.

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2022
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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