NCT05254067

Enterprise 2 Vascular Reconstruction Device

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aneurysm

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-28
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2022-02-24
• Last updated: 2024-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study