MedTrace Logo

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

NCT02719522 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 205

Last updated 2022-01-11

Study results available
· View outcomes & findings →

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.

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.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    collaborator INDUSTRY

  • Medtronic Neurovascular Clinical Affairs

    lead INDUSTRY

Principal Investigators

  • Saleh Lamin · The Queen Elizabeth Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-08-22
Completion
2019-08-22

Countries

  • Australia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02719522 on ClinicalTrials.gov