FIRST: Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms. [At 12-months (-3 / + 6 months) post procedure]
Characterized by the rate of the permanent neurologic deficits and procedure related mortality.
- Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms. [At 12-months (-3 / + 6 months) post procedure]
Characterized by the clinical outcome assessed by mRS of the permanent neurologic deficits and procedure related mortality.
Secondary Outcome Measures
- Safety of silk vista and silk vista baby [At T0]
Assessed by the rate of adverse events
- Safety of silk vista and silk vista baby [At hospital discharge]
Assessed by the rate of adverse events
- Safety of silk vista and silk vista baby [Up to 30 days (-10 / + 21 days) post- procedure.]
Assessed by the rate of adverse events
- Safety of silk vista and silk vista baby [At 6 months (-2/+3 months) post- procedure.]
Assessed by the rate of adverse events
- Safety of silk vista and silk vista baby [At 12 months (-3/+6 months) post- procedure.]
Assessed by the rate of adverse events
- Safety of silk vista and silk vista baby [At 3 years post procedure]
Assessed by the rate of adverse events
- Safety of silk vista and silk vista baby [At 5 years post procedure]
Assessed by the rate of adverse events
- Efficacy of silk vista and silk vista baby [At T0]
Assessed by aneurysm occlusion rate
- Efficacy of silk vista and silk vista baby [At hospital discharge]
Assessed by aneurysm occlusion rate
- Efficacy of silk vista and silk vista baby [Up to 30 days (-10 / + 21 days) post- procedure.]
Assessed by aneurysm occlusion rate
- Efficacy of silk vista and silk vista baby [Up to 6 months (-2/+3 months) post- procedure]
Assessed by aneurysm occlusion rate
- Efficacy of silk vista and silk vista baby [Up to 12 months (-3 / + 6 months) post procedure]
Assessed by aneurysm occlusion rate
- Efficacy of silk vista and silk vista baby [Up to 3 years post procedure]
Assessed by aneurysm occlusion rate
- Efficacy of silk vista and silk vista baby [Up to 5 years post procedure]
Assessed by aneurysm occlusion rate
- Technical procedure [At T0]
The practices related to the use of silk vista baby will be describe
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient with intracranial aneurysms intended to be treated with the silk vista and silk vista baby (decision of use silk vista and silk vista baby is done independently and prior to the participation of the patient in the study)
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Patients with recanalized aneurysms previously treated with coils exclusively are also eligible.
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In case of multiple aneurysms, only treatment with silk vista and silk vista baby are allowed (between the initial index procedure to the 12 months follow up visit)
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Patient ≥ 18 years, who signed an informed consent.
Exclusion Criteria:
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Patient presenting with contra-indications to the use of silk vista and silk vista babyaccording to the IFU (Instruction for Use).
-
Recanalized aneurysms initially treated with stent (including stent assisted coiling)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitätsklinik für Neurologie | Salzburg | Austria | A-5020 | |
| 2 | CHC Saint Joseph Liège | Liège | Belgium | 4000 | |
| 3 | University Hospital Centre Zagreb | Zagreb | Croatia | 10000 | |
| 4 | CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | France | 33000 | |
| 5 | Hopital Cavale Blanche | Brest | France | 29200 | |
| 6 | Hospices Civils de Lyon - Hôpital Neurologique | Bron | France | 69677 | |
| 7 | CHU Caen, Radiologie interventionelle | Caen | France | 14033 | |
| 8 | Hôpital Kremlin Bicêtre | Le Kremlin-Bicêtre | France | 94270 | |
| 9 | Chu Dupuytren Limoges | Limoges | France | 87000 | |
| 10 | Fondation Rothschild | Paris | France | 75019 | |
| 11 | Pitié-Salpêtrière Hospital | Paris | France | 75651 | |
| 12 | CHU Chalre Nicolle | Rouen | France | 76000 | |
| 13 | Munich LMU University | München | Germany | 81377 | |
| 14 | Hadassah Medical Center | Jerusalem | Israel | 9112001 | |
| 15 | Galilee Medical Center | Nahariya | Israel | 22100 | |
| 16 | Niguarda Hospital | Milan | Italy | 20162 | |
| 17 | San Gerardo Hospital | Monza | Italy | 20900 | |
| 18 | Cà Foncello Hospital | Treviso | Italy | 31100 | |
| 19 | Santa maria della misericordia hospital | Udine | Italy | 33100 | |
| 20 | Radboud University medical Center | Nijmegen | Netherlands | 6525 G | |
| 21 | Hospital Universitario de cruces | Baracaldo | Spain | 48903 | |
| 22 | Ramon y Cajal hospital | Madrid | Spain | 28034 | |
| 23 | Hopsital universidad puerta de hierro | Madrid | Spain | 28222 | |
| 24 | Unversitario Central de Asturias | Oviedo | Spain | 33011 | |
| 25 | Hospital Clinico Universitario de Valladolid | Valladolid | Spain | 47003 |
Sponsors and Collaborators
- Balt Extrusion
Investigators
- Principal Investigator: Mario Martinez Galdamez, Dr, Hospital Clinico Universitario de Valladolid (HCUV), Spain
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP 201802 SILK VISTA