CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 205 enrolled
Drug / intervention
Pipeline™ Flex Embolization Device with Shield Technology™device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02719522
NCT02719522N/ACompleted
CompareCT.gov

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

Medtronic Neurovascular Clinical Affairs·observational·Posted Mar 25, 2016·Updated Jan 11, 2022

In Brief

An observational study evaluating Pipeline™ Flex Embolization Device with Shield Technology™ for Intracranial Aneurysm. Completed, enrolled 205 participants across 21 sites in 11 countries.

Detailed Summary

This is a prospective, single-arm, multi-center post-market observational study assessing the performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects undergoing treatment for intracranial aneurysms in a large real-world, post-market setting.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsIntracranial Aneurysm
CountriesAustralia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Spain, United Kingdom
CollaboratorsMedtronic Cardiac Rhythm and Heart Failure

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 25, 2016
Enrollment StartMar 1, 2016
Primary CompletionAug 22, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.3 years ago

Interventions

Pipeline™ Flex Embolization Device with Shield Technology™device

Pipeline™ Flex Embolization Device with Shield Technology™ utilizes a phosphorylcholine (PC) surface treatment to the implant combined with the PFED delivery system. The Shield Technology™ surface treatment applied to the implant is an inert polymer material created to mimic the outer membrane of a human red blood cell. The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for endovascular embolization of cerebral aneurysms and is designed to be placed across the opening (or 'neck') of a brain aneurysm and redirect blood flow away from the aneurysm, causing the blood within the aneurysm to clot.