Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy (SHIELD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02719522|
Recruitment Status : Active, not recruiting
First Posted : March 25, 2016
Last Update Posted : January 28, 2019
|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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy of Treated Intra Cranial Aneurysms (SHIELD)|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||September 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.
- Rate of stroke/neurologic death occurred at 1 year [ Time Frame: 1 year ]
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
|Gold Coast University Hospital|
|Southport, Australia, QLD 4215|
|Copenhagen, Denmark, 2100|
|Hospital Fundación Jiménez Díaz|
|Madrid, Spain, 28040|
|Queen Elizabeth Hospital|
|Birmingham, United Kingdom, B15 2TH|
|Study Chair:||Saleh Lamin||Queen Elizabeth Hospital|