NCT06793059

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Jan 2027

Study Start

First participant enrolled

January 1, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

January 20, 2025

Last Update Submit

March 6, 2026

Conditions

Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Occurrence of thromboembolic event(s)

    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.

    12 Months

Study Arms (1)

SHIELD Study Arm

OTHER

Active treatment with the Pipeline SHIELD Device

Device: SHIELD

Interventions

SHIELDDEVICE

Pipeline SHIELD device under study

SHIELD Study Arm

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 Criteria:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacobs Institute

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Carlos Pena, PhD, MS

CONTACT

2404810824cpena@jacobsinstitute.org

Study Design

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

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 27, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

US(1)