Actively Recruiting
Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm (SHIELD)
Led by Jacobs institute · Updated on 2026-03-10
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Pipeline22 Flex Embolization Device with Shield Technology22 for treating adults aged 22 years and older who have large or giant wide-necked intracranial aneurysms in specific parts of the internal carotid artery. This device is also studied for smaller wide-necked aneurysms arising from parent vessels of certain sizes. The study aims to collect clinical evidence on the approved use of this device for endovascular treatment of these aneurysms. Participants will receive treatment with the Pipeline SHIELD Device, which is a flow diverter technology designed to manage intracranial aneurysms. The treatment involves endovascular placement of the device in the affected artery segments as specified. There is one study arm using this active treatment device. The study does not involve masking or blinding. During the study, participants will be monitored for the occurrence of thromboembolic events over a 12-month period. Researchers will evaluate safety outcomes related to these events. The overall study period spans from the start date in 2025 through an observation of outcomes up to 12 months after treatment. Participants will be adults able to provide consent or have a legally authorized representative available.
CONDITIONS
Brief Title
Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm (SHIELD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 22 years of age or older
- Diagnosis of large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments
- Able to provide consent or have a legally authorized representative available to provide consent
You will not qualify if you...
- Unable to provide consent and no legally authorized representative available to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants receive the Pipeline SHIELD device for the endovascular treatment of intracranial aneurysms.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety and effectiveness after device implementation.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Jacobs Institute
Buffalo, New York, United States, 14203
Actively Recruiting
Research Team
C
Carlos Pena, PhD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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