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

Purpose

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

Condition

  • Aneurysm

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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:

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Surgical System Intervention
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
SHIELD Study Arm 		Active treatment with the Pipeline SHIELD Device
  • Device: SHIELD
    Pipeline SHIELD device under study

Recruiting Locations

Jacobs Institute
Buffalo, New York 14203

More Details

Status
Recruiting
Sponsor
Jacobs institute

Study Contact

Carlos Pena, PhD, MS
2404810824
cpena@jacobsinstitute.org

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.