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