NCT00928265

Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 116 (actual)
• Sponsor: Stryker Neurovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Endovascular treatment of intracranial aneurysm.	Neuroform stent is used in conjunction of occlusives devices such as coils. Neuroform Stent allows the treatment of wide neck aneurysm with embolic coils. Put in front of the wide neck, it keeps the coils into the aneurysm and avoids them to fall in the parent artery, preventing coil protrusion. Accomplishes this by providing coil support at the neck of the aneurysm

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-09-01
• Completion: 2010-12-01
• First posted: 2009-06-25
• Last updated: 2013-06-04

Locations

12 sites across 1 country: France