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RecruitingNCT06793059SHIELDUpdated Mar 10, 2026

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

An interventional study of SHIELD in Aneurysm, sponsored by Jacobs institute. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Jacobs institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
22 Years and older
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Aneurysm

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03

In context

Aneurysm

381 studies on the registry are indexed under Aneurysm; 78 are open to participants now.

This study's planned enrollment of 10 is below the median of 46 across 235 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Jacobs institute is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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:
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Other
    SHIELD Study Arm

    Active treatment with the Pipeline SHIELD Device

    Device: SHIELD

Interventions

  • DeviceSHIELD

    Pipeline SHIELD device under study

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What researchers measure

Primary outcomes

  1. Occurrence of thromboembolic event(s)

    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.

    Time frame: 12 Months

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06793059
Lead sponsor
Jacobs institute
Responsible party
Elad Levy (Principal Investigator, Jacobs institute) — Principal investigator
First posted
Jan 27, 2025
Start date
Jan 1, 2025
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Mar 10, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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