CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 116 enrolled
Drug / intervention
Endovascular treatment of intracranial aneurysm.device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00928265
NCT00928265N/ACompleted

Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

Stryker Neurovascular·observational·Posted Jun 25, 2009·Updated Jun 4, 2013

In Brief

An observational study evaluating Endovascular treatment of intracranial aneurysm. for Intracranial Aneurysm. Completed, enrolled 116 participants across 12 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 25, 2009
Enrollment StartJul 1, 2008
Primary CompletionSep 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.0 years ago

Interventions

Endovascular treatment of intracranial aneurysm.device

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