Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

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.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier pellegrin, Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Neuroform3TM Microdelivery Stent System, M003E3250100,M003E3250150,M003E3250200,, M003E3300100,M003E3300150,M003E3300200,M003E3300300, M003E3350100,M003E3350150,M003E3350200,M003E3350300, M003E3400100,M003E3400150,M003E400200,M003E400300, M003E3450100,M003E3450150,M003E3450200,M003E3450300

Primary outcomes

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).

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Stryker Neurovascular

Industry

Registry information

Acronym: SENAT

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Jun 25, 2009
Registry last updated: Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed