Enterprise 2 Vascular Reconstruction Device

Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05254067
• Other study ID #: 001.VAS.2017.D
• Status: Enrolling by invitation
• Start date: February 28, 2017
• Est. completion date: February 2025

Study information

• Verified date: July 2023
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm

Intervention

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.

Locations

Country	Name	City	State
United States	Moody Brain and Spine Institute at Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.