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

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Jacobs institute (other)
• Locations: 1 site (Buffalo, New York)
• Trial ID: NCT06793059 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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:

Where this trial is running

Buffalo, New York

• Jacobs Institute — Buffalo, New York, United States (RECRUITING)

Study contacts

• Study coordinator: Carlos Pena, PhD, MS

Conditions: Aneurysm