Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

Stryker Neurovascular116 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

116

Conditions

Intracranial Aneurysm

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Centre Hospitalier pellegrin

Bordeaux, France

CHU Hôpital de la Côte de Nacre

Caen, France

CHRU Salengro

Lille, France

CHU Limoges

Limoges, France

Hôpital Neurologique

Lyon, France

Hôpital Gui de Chauliac

Montpellier, France

CHU Nancy

Nancy, France

CHU Hôpital Guillaume et René Laënnec

Nantes, France

Hôpital Saint-Roch

Nice, France

Hôpital Lariboisière

Paris, France

...and 2 more locations

Outcomes

Primary Outcomes

Morbidity and Mortality associated with stenting and coiling

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).

Time frame: 30 days and 12-18 months post procedure

Secondary Outcomes

Efficacy of the Neuroform stent for treatment of wide neck aneurysms

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

Time frame: post procedure and at 12-18 months post procedure