The FIRST study is an observational, prospective, multi-center, international, single-arm, study. The aim of the study is to collect safety and efficacy information on the use of the silk vista and silk vista baby flow diverter in order to assess clinical safety and performance of the device for treating intracranial aneurysms. All patients with intracranial aneurysm ruptured or unruptured, whatever the localization of the aneurysm, and treated with silk vista or silk vista baby, will be consecutively enrolled in the study. The patient's inclusion and follow up in the study will occur as part of their usual standard of care.
Study Type
OBSERVATIONAL
Enrollment
234
Patients with intracranial aneurysm(s) intended to be treated with the silk vista and silk vista baby according to standard of care.
Universitätsklinik für Neurologie
Salzburg, Austria
CHC Saint Joseph Liège
Liège, Belgium
University Hospital Centre Zagreb
Zagreb, Croatia
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
Hopital Cavale Blanche
Brest, France
Hospices Civils de Lyon - Hôpital Neurologique
Bron, France
CHU Caen, Radiologie interventionelle
Caen, France
Centre Hospitalier Universitaire Clermont Ferrand
Clermont-Ferrand, France
Centre Hospitalier Universitaire de Grenoble Alpes
Grenoble, France
Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre, France
...and 19 more locations
Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms.
Characterized by the rate of the permanent neurologic deficits and procedure related mortality.
Time frame: At 12-months (-3 / + 6 months) post procedure
Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms.
Characterized by the clinical outcome assessed by mRS of the permanent neurologic deficits and procedure related mortality.
Time frame: At 12-months (-3 / + 6 months) post procedure
Safety of silk vista and silk vista baby
Assessed by the rate of adverse events
Time frame: At T0
Safety of silk vista and silk vista baby
Assessed by the rate of adverse events
Time frame: At hospital discharge
Safety of silk vista and silk vista baby
Assessed by the rate of adverse events
Time frame: Up to 30 days (-10 / + 21 days) post- procedure.
Safety of silk vista and silk vista baby
Assessed by the rate of adverse events
Time frame: At 6 months (-2/+3 months) post- procedure.
Safety of silk vista and silk vista baby
Assessed by the rate of adverse events
Time frame: At 12 months (-3/+6 months) post- procedure.
Safety of silk vista and silk vista baby
Assessed by the rate of adverse events
Time frame: At 3 years post procedure
Safety of silk vista and silk vista baby
Assessed by the rate of adverse events
Time frame: At 5 years post procedure
Efficacy of silk vista and silk vista baby
Assessed by aneurysm occlusion rate
Time frame: At T0
Efficacy of silk vista and silk vista baby
Assessed by aneurysm occlusion rate
Time frame: At hospital discharge
Efficacy of silk vista and silk vista baby
Assessed by aneurysm occlusion rate
Time frame: Up to 30 days (-10 / + 21 days) post- procedure.
Efficacy of silk vista and silk vista baby
Assessed by aneurysm occlusion rate
Time frame: Up to 6 months (-2/+3 months) post- procedure
Efficacy of silk vista and silk vista baby
Assessed by aneurysm occlusion rate
Time frame: Up to 12 months (-3 / + 6 months) post procedure
Efficacy of silk vista and silk vista baby
Assessed by aneurysm occlusion rate
Time frame: Up to 3 years post procedure
Efficacy of silk vista and silk vista baby
Assessed by aneurysm occlusion rate
Time frame: Up to 5 years post procedure
Technical procedure
The practices related to the use of silk vista baby will be describe
Time frame: At T0
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