Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent (CHOICE)

NCT ID: NCT03413852

Last Updated: 2021-04-30

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-11

Study Completion Date

2022-08-31

Brief Summary

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The objective of this study is to further establish that SQUID, an alternative liquid embolic agent with specific properties, is a safe and effective alternative in bAVM endovascular treatment strategy available to date. Therefore, the performance of SQUID will be documented and its safety of use will be confirmed in current practice.

Detailed Description

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Conditions

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Cerebral Arteriovenous Malformation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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SQUID non-adhesive liquid embolic agent

AVM embolization using SQUID non-adhesive liquid embolic agent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient planned for one or multiple embolization sessions using SQUID to achieve occlusion of a previously untreated bAVM.\*

\*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 not eligible for endovascular treatment.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Embo-Flüssigkeiten A.G.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Antwerp

Edegem, , Belgium

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

CHU Bordeaux

Bordeaux, , France

Site Status

CHU Brest

Brest, , France

Site Status

Hospices Civils de Lyon

Bron, , France

Site Status

CHU Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Hôpital Central

Nancy, , France

Site Status

Hôpital Lariboisière

Paris, , France

Site Status

Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status

Hôpital Maison Blanche

Reims, , France

Site Status

CHU Rouen

Rouen, , France

Site Status

CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

CHU Toulouse

Toulouse, , France

Site Status

Zentralklinikum Augsburg

Augsburg, , Germany

Site Status

Klinikum der Ruhr-Universität Bochum, Knappschaftskrankenhaus

Bochum, , Germany

Site Status

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Site Status

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Klinikum Grosshadern

Munich, , Germany

Site Status

San Gerardo Monza

Monza, , Italy

Site Status

Countries

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Belgium Denmark France Germany Italy

Other Identifiers

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CIP-201701-SQUID

Identifier Type: -

Identifier Source: org_study_id

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