Clinical Trial: Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: PREMIER PROSPECTIVE STUDY ON EMBOLIZATION OF INTRACRANIAL ANEURYSMS WITH PIPELINE™ EMBOLIZATION DEVICE

Brief Summary: The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.

Detailed Summary:
Sponsor: Medtronic Neurovascular Clinical Affairs

Current Primary Outcome:

  • Occurrence of major stroke or neurological death [ Time Frame: 1 year ]
  • Complete aneurysm occlusion [ Time Frame: 1 year ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Occurrence of major stroke or neurological death [ Time Frame: 30 day ]

Original Secondary Outcome: Same as current

Information By: Medtronic Neurovascular Clinical Affairs

Dates:
Date Received: July 8, 2014
Date Started: July 2014
Date Completion: November 2019
Last Updated: May 25, 2016
Last Verified: May 2016