Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent (CHOICE)
NCT ID: NCT03413852
Last Updated: 2021-04-30
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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UNKNOWN
111 participants
OBSERVATIONAL
2018-05-11
2022-08-31
Brief Summary
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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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SQUID non-adhesive liquid embolic agent
AVM embolization using SQUID non-adhesive liquid embolic agent
Eligibility Criteria
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Inclusion Criteria
\*Patients with a direct fistula or saccular/flow-related aneurysm previously treated with NBCA and/or coils may be included.
* Patient in whom the use of SQUID had been decided for an embolization alone or in association to neurosurgery or radiotherapy.
* Patient ≥18 years old.
* Patient or authorized representative dully informed and having no objection to the clinical data collection and medical file access. An informed consent form must be signed and dated whenever required by local legislation
Exclusion Criteria
* Patient with bAVM previously treated by embolization with other devices (Liquid embolic agent, NBCA, particles, and coils).\*
\*Patients with a direct fistula or saccular / flow-related aneurysm previously treated with NBCA and/or coils may be included.
* Patient with bAVM previously treated with surgery or radiotherapy.
* Patient intended to undergo surgery and embolization during the same procedure at first embolization
* Patient with multiple bAVM or bAVM associated with dural arteriovenous Fistula\*.
\*Patients with a direct fistula or saccular / flow-related aneurysm previously treated with NBCA and/or coils may be included.
* Patient presenting contra-indication to the use of SQUID according to the Instructions For Use.
* Intention to treat with any non-adhesive embolic liquid other than SQUID, or planned treatment with another non-adhesive embolic liquid over the course of the endovascular treatment phase.
* Patient planned for a total endovascular treatment phase duration exceeding 2 years.
* Patient participating in another clinical study evaluating another medical device, another procedure or a medication.
* Any condition or any situation that would prohibit the patient from coming to the investigational center for the follow-up as recommended by the study protocol between 3 and 6 months, or prohibit carrying out the telephone mRS assessments at 1 month after each embolization session and at 12 months after the end of the endovascular treatment phase.
18 Years
ALL
No
Sponsors
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Embo-Flüssigkeiten A.G.
INDUSTRY
Responsible Party
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Locations
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University Hospital Antwerp
Edegem, , Belgium
Odense University Hospital
Odense, , Denmark
CHU Bordeaux
Bordeaux, , France
CHU Brest
Brest, , France
Hospices Civils de Lyon
Bron, , France
CHU Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital Central
Nancy, , France
Hôpital Lariboisière
Paris, , France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, , France
Hôpital Maison Blanche
Reims, , France
CHU Rouen
Rouen, , France
CHU de Saint-Etienne
Saint-Etienne, , France
CHU Toulouse
Toulouse, , France
Zentralklinikum Augsburg
Augsburg, , Germany
Klinikum der Ruhr-Universität Bochum, Knappschaftskrankenhaus
Bochum, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Klinikum Grosshadern
Munich, , Germany
San Gerardo Monza
Monza, , Italy
Countries
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Other Identifiers
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CIP-201701-SQUID
Identifier Type: -
Identifier Source: org_study_id
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