Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
10 participants
OBSERVATIONAL
2017-02-28
2025-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Device recipient
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability to tolerate anti-platelet medication.
18 Years
ALL
No
Sponsors
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Methodist Health System
OTHER
Responsible Party
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Principal Investigators
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Bartley Mitchell, MD
Role: PRINCIPAL_INVESTIGATOR
Methodist Dallas Medical Center Neurovascular Surgery
Locations
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Moody Brain and Spine Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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001.VAS.2017.D
Identifier Type: -
Identifier Source: org_study_id
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