Clinical trial Recruiting at 1 site Interventional Ages 22 and up

Pipeline Flex with Shield flow-diverter for wide‑neck intracranial aneurysms

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

Run by Jacobs institute · NCT06793059 · Data updated 2026-11-12

The Pipeline Flex Embolization Device with Shield Technology will be tested in adults 22 and older who have wide‑necked intracranial aneurysms in specified parts of the internal carotid artery.

Quick facts

Study typeInterventional
Ages22 Years and up
SexAll
Enrollment10 (estimated)
SponsorJacobs institute
Academic / other
Locations1 site (Buffalo, New York)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedJanuary 1, 2027
Study endsJanuary 1, 2027
Registry record updatedMarch 10, 2026
Trial IDNCT06793059 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 22 and older with large or giant wide‑neck aneurysms in the internal carotid artery from the petrous to superior hypophyseal segments, or with small/medium wide‑neck saccular or fusiform aneurysms up to the terminus and a parent vessel diameter of 2.0–5.0 mm, are ideal candidates.

Probably not a fit

Patients with aneurysms outside the specified ICA segments, parent vessel diameters outside 2.0–5.0 mm, those who cannot take required antiplatelet therapy, or those unable to provide consent are unlikely to benefit from this device in this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, prospective program uses the Pipeline Flex Embolization Device with Shield Technology as an endovascular flow‑diversion treatment for adults aged 22 and older with defined wide‑neck intracranial aneurysms. Eligible patients will undergo device implantation by a neurointerventionalist and return for scheduled imaging and clinical follow‑up to document aneurysm occlusion and safety outcomes. The Shield surface treatment is intended to reduce device thrombogenicity compared with earlier devices, and the study will collect real‑world data on technical success, occlusion rates, and adverse events. Outcomes will help clarify performance across the specified aneurysm sizes, morphologies, and parent vessel diameters.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive option to close wide‑neck aneurysms and reduce the risk of rupture or need for additional procedures.

How similar studies have gone: Earlier Pipeline flow‑diverter devices have shown high aneurysm occlusion rates and acceptable safety in prior studies, and Shield Technology builds on that experience with preliminary supportive data on reduced thrombogenicity.

Who can join: the full rules

Show full inclusion / exclusion 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:

Where it's running

  • Jacobs Institute
    Buffalo, New York, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.