Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy

CompletedOBSERVATIONAL
Enrollment

205

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

August 22, 2019

Study Completion Date

August 22, 2019

Conditions
Intracranial Aneurysm
Interventions
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."

Trial Locations (21)

2100

Rigshospitalet, Copenhagen

28040

Hospital Fundación Jiménez Díaz, Madrid

QLD 4215

Gold Coast University Hospital, Southport

Unknown

Turun Yliopistollinen keskussairaala, Turku

Hôpital Bicêtre, Le Kremlin-Bicêtre

Universitätsklinikum Augsburg, Augsburg

Charité Centrum, Berlin

Alfried Krupp Krankenhaus, Essen

Universitätsklinikums Heidelberg, Heidelberg

Universitätsklinikum des Saarlandes, Homburg

Hellenic Airforce Hospital, Athens

Országos Klinikai Idegtudományi Intézet, Budapest

Hadassah Medical Organization, Jerusalem

Ospedale M. Bufalini, Cesena

Istituto Neurologico Carlo Besta, Milan

Hospital Universitario Cruces, Barakaldo

Hospital Universitario de la Princesa, Madrid

Hospital Universitario Puerta de Hierro, Madrid

Hospital Universitario Central de Asturias, Oviedo

Royal Preston Hospital, Preston

B15 2TH

Queen Elizabeth Hospital, Birmingham

All Listed Sponsors
collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

lead

Medtronic Neurovascular Clinical Affairs

INDUSTRY

NCT02719522 - Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy | Biotech Hunter | Biotech Hunter