Completed

SHIELDPipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy of Treated Intra Cranial Aneurysms (SHIELD)

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Aneurysm+6

+ Brain Diseases

+ Cardiovascular Diseases

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2016
See protocol details

Summary

Principal SponsorMedtronic Neurovascular Clinical Affairs
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2016

Actual date on which the first participant was enrolled.

Eligible subjects will be treated with the Pipeline™ Flex Embolization Device with Shield Technology™. Subjects will undergo standard of care follow-up visits. Data generated per standard of care will be collected for 1 year beyond the index procedure. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Official TitlePipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy of Treated Intra Cranial Aneurysms (SHIELD)
NCT02719522
Principal SponsorMedtronic Neurovascular Clinical Affairs
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

205 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AneurysmBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesIntracranial AneurysmCerebrovascular DisordersNervous System DiseasesVascular DiseasesIntracranial Arterial Diseases

Criteria

4 inclusion criteria required to participate
Subject has provided written Data Release Form (DRF) or informed consent using the Institutional Review Board (IRB)/ Ethic Committee (EC)-approved consent form and agrees to comply with protocol requirements.
At least 18 years of age.
Subject has already been selected for flow diversion therapy as the appropriate treatment.
Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA.
10 exclusion criteria prevent from participating
Major surgery including endovascular procedures within the past 30 days.
Subject with target IA located in the basilar artery
Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy.
Stent is in place in the parent artery at the target IA location.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 21 locations

Suspended

Gold Coast University Hospital

Southport, AustraliaOpen Gold Coast University Hospital in Google Maps
Suspended

Rigshospitalet

Copenhagen, Denmark
Suspended

Turun Yliopistollinen keskussairaala

Turku, Finland
Suspended

Hôpital Bicêtre

Le Kremlin-Bicêtre, France
Completed21 Study Centers