Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment (SENAT)

Stryker

Status: Completed

Conditions: Intracranial Aneurysm

Treatments: Device: Endovascular treatment of intracranial aneurysm.

Study type: Observational

Funder types: Industry

Identifiers

NCT00928265

SENAT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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