Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy (SHIELD)
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|ClinicalTrials.gov Identifier: NCT02719522|
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : July 8, 2020
Last Update Posted : January 11, 2022
|Condition or disease||Intervention/treatment|
|Intracranial Aneurysm||Device: Pipeline™ Flex Embolization Device with Shield Technology™|
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.)
|Study Type :||Observational|
|Actual Enrollment :||205 participants|
|Official Title:||Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy of Treated Intra Cranial Aneurysms (SHIELD)|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||August 22, 2019|
|Actual Study Completion Date :||August 22, 2019|
- Device: Pipeline™ Flex Embolization Device with Shield Technology™
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.
- Safety - Stroke/Death Occurrence [ Time Frame: 1 year ]Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death post-procedure (1-year)
- Effectiveness - Aneurysm Occlusion [ Time Frame: 1 year ]Percentage (%) of Participants who have achieved complete aneurysm occlusion (defined as Raymond-Roy grade 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm post-procedure (1-year)
- Safety - Stroke/Death Occurrence - 30 Days [ Time Frame: 30 days ]Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death at 30 days post-procedure due to procedural complications
- Safety - Intracerebral Hemorrhage (ICH) [ Time Frame: 1 year ]Percentage (%) of Participants who experienced a delayed intracerebral hemorrhage > 30 days post-procedure
- Effectiveness - Deployment Rate [ Time Frame: 1 year ]
Percentage (%) of Participants who have had a successful deployment of the device at the target site.
A device is considered properly deployed when it covers the entire length of the aneurysm neck.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719522
|Study Chair:||Saleh Lamin||The Queen Elizabeth Hospital|