Clinical trial NCT03413852: Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent (CHOICE)
Official title: Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent - The CHOICE Study A Non-interventional, Prospective, Single-arm, International, Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Arteriovenous Malformation
Lead sponsor: Embo-Flüssigkeiten A.G.
Sponsor class: INDUSTRY
First posted: 2018-01-29
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients planned for embolization using SQUID to achieve occlusion of a previously untreated bAVM.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: modified Rankin Score (mRS)
timeFrame: 3 to 6 months after the last embolisation session
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Odense
country: Denmark
facility: Odense University Hospital
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: CHU Brest
city: Bron
country: France
facility: Hospices Civils de Lyon
city: Le Kremlin-Bicêtre
country: France
facility: CHU Bicêtre
city: Nancy
country: France
facility: Hôpital Central
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Reims
country: France
facility: Hôpital Maison Blanche
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Toulouse
country: France
facility: CHU Toulouse
city: Augsburg
country: Germany
facility: Zentralklinikum Augsburg
city: Bochum
country: Germany
facility: Klinikum der Ruhr-Universität Bochum, Knappschaftskrankenhaus
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Munich
country: Germany
facility: Klinikum Grosshadern
city: Monza
country: Italy
facility: San Gerardo Monza
Study officials:
References: