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:

  1. 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).
  2. to evaluate adverse events.
  3. 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 ]

Assessment of morbidity and mortality at 30 days and 12-18 months post endovascular treatment of wide neck aneurysm with a Neurform 3 stent and coiling as assessed by the modified Rankin scale (mRS).


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 ]

Assessment of the morphological results post endovascular coiling and stenting of wide neck aneurysms and assessment of anatomical stability of the treatment 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