Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm (SHIELD)
ConditionAneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorJacobs institute
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
SHIELD
DevicePipeline SHIELD device under study
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: SHIELD Study ArmOther 1 intervention
Trial outcomes
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.
Time frame
12 MonthsSponsors and contacts
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Source ClinicalTrials.gov