Clinical Trial: Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment
Brief Summary:
This is a prospective observational multicenter registry to evaluate safety and efficacy data on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an intent to treat basis.
The objectives of this study are:
- Assessment of morbidity-mortality at 1 month and 12-18 months following the treatment of the intracranial aneurysm with Neuroform3TM stent and endovascular coiling using the modified Rankin scale (mRS).
- to evaluate adverse events.
- Angiographic assessment at 12-18 months compared to the initial post-treatment assessment via the modified Raymond scale and same/better/worse scale.
Detailed Summary: There is an increasing perception in the Neurovascular community - supported by extensive peer-to-peer and congress communications - that "stent-assisted coiling" of intracranial wide neck aneurysms improves the long term angiographic outcome of treated patients.
Sponsor: Stryker Neurovascular
Current Primary Outcome: Morbidity and Mortality associated with stenting and coiling [ Time Frame: 30 days and 12-18 months post procedure ]
Original Primary Outcome:
Current Secondary Outcome: Efficacy of the Neuroform stent for treatment of wide neck aneurysms [ Time Frame: post procedure and at 12-18 months post procedure ]
Original Secondary Outcome:
Information By: Stryker Neurovascular
Dates:
Date Received: June 23, 2009
Date Started: July 2008
Date Completion:
Last Updated: May 31, 2013
Last Verified: May 2013