Recruiting

Pipeline™ Flex

Sponsor:

Jacobs institute

Code:

NCT06793059

Conditions

Aneurysm

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

SHIELD

Study Details

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

Aneurysm

Study ID

NCT06793059

Start date

Jan 1, 2025

Status verified date

Mar, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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:

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: SHIELD Study Arm

Active treatment with the Pipeline SHIELD Device

Interventions

SHIELD

Pipeline SHIELD device under study

Primary outcome measure

  • Occurrence of thromboembolic event(s) [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Carlos Pena, PhD, MS

2404810824cpena@jacobsinstitute.org

Locations

Jacobs Institute

Recruiting

Buffalo, New York, United States, 14203

More Information

Sponsor

Jacobs institute

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jacobs institute on 2026-03-10.