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NCT06793059NARecruiting

Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm (SHIELD)

Jacobs institute

Start Date

1/1/2025

Completion Date

1/1/2027

Summary

The Jacobs Institute is participating in a study designed to collect prospective clinical evidence to evaluate the approved use of the Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with wide-necked intracranial aneurysms

Detailed Description

The Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. The Pipeline™ Flex Embolization Device with Shield Technology™ is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio \< 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.

Eligibility Criteria

Age Range: 22 years to No maximum

Inclusion Criteria: * Adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. Exclusion Criteria: Exclusion Criteria: * Cannot provide consent or legally authorized representative not available to provide consent Criteria:

Interventions

DEVICE

SHIELD

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Conditions

Aneurysm

Locations

Jacobs Institute

Buffalo, New York 14203

United States