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

Carlos Pena, PhD, MS

Status and phase

Active, not recruiting

Phase 1

Conditions

Aneurysm

Treatments

Device: SHIELD

Study type

Interventional

Funder types

Other

Identifiers

NCT06793059

CIP-001

SHIELD

Details and patient eligibility

About

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

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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: