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 type | Interventional |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Jacobs institute Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT06793059 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
- Study coordinator: Carlos Pena, PhD, MS
- Email: cpena@jacobsinstitute.org
- Phone: 2404810824
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.