Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment
NCT ID: NCT04034810
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
234 participants
OBSERVATIONAL
2019-11-04
2027-11-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Intracranial aneurysm treated with Silk vista and silk vista baby
Patients with intracranial aneurysm(s) intended to be treated with the silk vista and silk vista baby according to standard of care.
Eligibility Criteria
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Inclusion Criteria
2. Patients with recanalized aneurysms previously treated with coils exclusively are also eligible.
3. 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)
4. Patient ≥ 18 years, who signed an informed consent.
Exclusion Criteria
2. Recanalized aneurysms initially treated with stent (including stent assisted coiling)
18 Years
ALL
No
Sponsors
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Balt Extrusion
INDUSTRY
Responsible Party
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Principal Investigators
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Mario Martinez Galdamez, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinico Universitario de Valladolid (HCUV), Spain
Locations
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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
Chu Dupuytren Limoges
Limoges, , France
Hôpital Privé Clairval
Marseille, , France
Fondation Rothschild
Paris, , France
Pitié-Salpêtrière Hospital
Paris, , France
CHU Chalre Nicolle
Rouen, , France
Centre Hospitalier Régional Universitaire de Tours
Tours, , France
Munich LMU University
München, , Germany
Hadassah Medical Center
Jerusalem, , Israel
Galilee Medical Center
Nahariya, , Israel
Niguarda Hospital
Milan, , Italy
San Gerardo Hospital
Monza, , Italy
Cà Foncello Hospital
Treviso, , Italy
Santa maria della misericordia hospital
Udine, , Italy
Radboud University medical Center
Nijmegen, , Netherlands
Hospital Universitario de cruces
Barakaldo, , Spain
Ramon y Cajal hospital
Madrid, , Spain
Hopsital universidad puerta de hierro
Madrid, , Spain
Unversitario Central de Asturias
Oviedo, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Countries
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Other Identifiers
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CIP 201802 SILK VISTA
Identifier Type: -
Identifier Source: org_study_id
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