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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracranial aneurysm treated with Silk vista and silk vista baby | Device | Patients with intracranial aneurysm(s) intended to be treated with the silk vista and silk vista baby according to standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At 12-months (-3 / + 6 months) post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | At T0 |
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with an intracranial aneurysm treated with silk vista and silk vista baby.
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| Name | Affiliation | Role |
|---|---|---|
| Mario Martinez Galdamez, Dr | Hospital Clinico Universitario de Valladolid (HCUV), Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Neurologie | Salzburg | A-5020 | Austria | |||
| CHC Saint Joseph Liège |
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| At hospital discharge |
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | Up to 30 days (-10 / + 21 days) post- procedure. |
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | At 6 months (-2/+3 months) post- procedure. |
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | At 12 months (-3/+6 months) post- procedure. |
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | At 3 years post procedure |
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | At 5 years post procedure |
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | At T0 |
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | At hospital discharge |
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | Up to 30 days (-10 / + 21 days) post- procedure. |
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | Up to 6 months (-2/+3 months) post- procedure |
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | Up to 12 months (-3 / + 6 months) post procedure |
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | Up to 3 years post procedure |
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | Up to 5 years post procedure |
| Technical procedure | The practices related to the use of silk vista baby will be describe | At T0 |
| Liège |
| 4000 |
| Belgium |
| University Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | 33000 | France |
| Hopital Cavale Blanche | Brest | 29200 | France |
| Hospices Civils de Lyon - Hôpital Neurologique | Bron | 69677 | France |
| CHU Caen, Radiologie interventionelle | Caen | 14033 | France |
| Centre Hospitalier Universitaire Clermont Ferrand | Clermont-Ferrand | 63003 | France |
| Centre Hospitalier Universitaire de Grenoble Alpes | Grenoble | 38043 | France |
| Hôpital Kremlin Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
| Chu Dupuytren Limoges | Limoges | 87000 | France |
| Hôpital Privé Clairval | Marseille | 13009 | France |
| Fondation Rothschild | Paris | 75019 | France |
| Pitié-Salpêtrière Hospital | Paris | 75651 | France |
| CHU Chalre Nicolle | Rouen | 76000 | France |
| Centre Hospitalier Régional Universitaire de Tours | Tours | 37044 | France |
| Munich LMU University | München | 81377 | Germany |
| Hadassah Medical Center | Jerusalem | 9112001 | Israel |
| Galilee Medical Center | Nahariya | 22100 | Israel |
| Niguarda Hospital | Milan | 20162 | Italy |
| San Gerardo Hospital | Monza | 20900 | Italy |
| Cà Foncello Hospital | Treviso | 31100 | Italy |
| Santa maria della misericordia hospital | Udine | 33100 | Italy |
| Radboud University medical Center | Nijmegen | 6525 G | Netherlands |
| Hospital Universitario de cruces | Barakaldo | 48903 | Spain |
| Ramon y Cajal hospital | Madrid | 28034 | Spain |
| Hopsital universidad puerta de hierro | Madrid | 28222 | Spain |
| Unversitario Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | 47003 | Spain |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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