Clinical trial NCT05254067: Enterprise 2 Vascular Reconstruction Device
Official title: Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization with the Codman Enterprise 2 Vascular Reconstruction Device.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Aneurysm
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be initially assessed and if included, will undergo procedure that includes use of the device.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Device Effectiveness-Stent Migration
timeFrame: 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.
measure: Device Effectiveness- Stent Fore-shortening
timeFrame: 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.
measure: Device Effectiveness- In-stent stenosis
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Moody Brain and Spine Institute at Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Dallas Medical Center Neurovascular Surgery
name: Bartley Mitchell, MD
role: PRINCIPAL_INVESTIGATOR
References: