Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm

NCT06411418 | Active Not Recruiting DMC FDA Device

• 1 other identifier: SHIELD 60 DAY CIP 81622
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Intracranial Aneurysms

Outcome Measures

Primary Outcomes (1)

• Occurrence of thromboembolic event(s)

  60 days

Study Arms (1)

Single arm study

EXPERIMENTAL

Occurrence of thromboembolic event(s)

Device: Pipeline™ Flex Embolization Device with Shield Technology™

Interventions

Pipeline™ Flex Embolization Device with Shield Technology™ DEVICE

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.

Single arm study

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cannot provide consent or legally authorized representative not available to provide consent

Sponsors & Collaborators

• Jacobs institute: lead

Study Sites (1)

University at Buffalo Neurosurgery

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elad LEvy, MD

  University at Buffalo Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 13, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)