Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

Completed

• Conditions: Intracranial Aneurysm

• Registration Number: NCT00928265
• Lead Sponsor: Stryker Neurovascular

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 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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-31
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• 18 year's old patient or above.
• every patient suffering from an un-ruptured or ruptured aneurysm, for whom the endovascular treatment approach using the Neuroform3TM stent is considered by the therapeutic team in charge.
• patient who has given his consent to participate to the study and to get his anonymized data collected

Exclusion Criteria

• patient with dissecting or fusiform aneurysm
• treatment of several aneurysms in the same procedure, except adjacent aneurysm treated by the same stent
• severe vasospasm
• aneurysm associated with an arterio-venous malformation
• use of another Neuroform3TM stent
• woman pregnant or nursing
• patients not likely to be followed upon (living abroad)
• people protected by justice (safeguard of law, supervision or trusteeship)
• patient unsuitable to the anti-thrombotic and/or to anticoagulants therapies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morbidity and Mortality associated with stenting and coiling	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).

Secondary Outcome Measures

Name	Time	Method
Efficacy of the Neuroform stent for treatment of wide neck aneurysms	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

Trial Locations

Locations (12)

CHU Nancy; 🇫🇷 Nancy, France

Hôpital Saint-Roch; 🇫🇷 Nice, France

CHU Hôpital de la Côte de Nacre; 🇫🇷 Caen, France

Centre Hospitalier pellegrin; 🇫🇷 Bordeaux, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France

Hôpital Neurologique; 🇫🇷 Lyon, France

CHRU Salengro; 🇫🇷 Lille, France

Groupe Hospitalier Pitié-Salpétrière; 🇫🇷 Paris, France

CHU Limoges; 🇫🇷 Limoges, France

CHU Hôpital Guillaume et René Laënnec; 🇫🇷 Nantes, France

Fondation Rotschild; 🇫🇷 Paris, France