Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment (SENAT)
|ClinicalTrials.gov Identifier: NCT00928265|
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : June 4, 2013
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:
- 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).
- to evaluate adverse events.
- Angiographic assessment at 12-18 months compared to the initial post-treatment assessment via the modified Raymond scale and same/better/worse scale.
|Condition or disease||Intervention/treatment|
|Intracranial Aneurysm||Device: Endovascular treatment of intracranial aneurysm.|
|Study Type :||Observational|
|Actual Enrollment :||116 participants|
|Official Title:||Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment|
|Study Start Date :||July 2008|
|Primary Completion Date :||September 2010|
|Study Completion Date :||December 2010|
Device: Endovascular treatment of intracranial aneurysm.
- Neuroform3TM Microdelivery Stent System
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
- 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).
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928265
|Centre Hospitalier pellegrin|
|Bordeaux, France, 33076|
|CHU Hôpital de la Côte de Nacre|
|Caen, France, 14033|
|Lille, France, 59037|
|Limoges, France, 87042|
|Lyon, France, 69394|
|Hôpital Gui de Chauliac|
|Montpellier, France, 34059|
|Nancy, France, 54035|
|CHU Hôpital Guillaume et René Laënnec|
|Nantes, France, 44035|
|Nice, France, 06000|
|Paris, France, 75010|
|Groupe Hospitalier Pitié-Salpétrière|
|Paris, France, 75013|
|Paris, France, 75019|
|Principal Investigator:||Alessandra Biondi|
|Principal Investigator:||Alain Bonafé|