Enterprise 2 Vascular Reconstruction Device

Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization With the Codman 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.

Study Overview

• Status: Completed
• Conditions: Aneurysm
• Intervention / Treatment: Device: Codman Enterprise 2 Vascular Reconstruction Device

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Moody Brain and Spine Institute at Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Participants will be initially assessed and if included, will undergo procedure that includes use of the device.

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Device recipient

Device: Codman Enterprise 2 Vascular Reconstruction 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Effectiveness-Stent Migration	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.	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.
Device Effectiveness- Stent Fore-shortening	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.	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.
Device Effectiveness- In-stent stenosis	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.	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.

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Bartley Mitchell, MD, Methodist Dallas Medical Center Neurovascular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): January 5, 2026
• Study Completion (Actual): January 5, 2026

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm
• Other Study ID Numbers: 001.VAS.2017.D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes