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

Cerebral Arteriovenous Malformation Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03413852
• Other study ID #: CIP-201701-SQUID
• Status: Active, not recruiting
• Start date: May 11, 2018
• Est. completion date: August 2022

Study information

• Verified date: April 2021
• Source: Embo-Flüssigkeiten A.G.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 111
• Est. completion date: August 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Cerebral Arteriovenous Malformation
• Congenital Abnormalities
• Hemangioma
• Intracranial Arteriovenous Malformations

Intervention

Device:
• SQUID non-adhesive liquid embolic agent
AVM embolization using SQUID non-adhesive liquid embolic agent

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem
Denmark	Odense University Hospital	Odense
France	CHU Bordeaux	Bordeaux
France	CHU Brest	Brest
France	Hospices Civils de Lyon	Bron
France	CHU Bicêtre	Le Kremlin-Bicêtre
France	Hôpital Central	Nancy
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	Hôpital Lariboisière	Paris
France	Hôpital Maison Blanche	Reims
France	CHU Rouen	Rouen
France	CHU de Saint-Etienne	Saint-Étienne
France	CHU Toulouse	Toulouse
Germany	Zentralklinikum Augsburg	Augsburg
Germany	Klinikum der Ruhr-Universität Bochum, Knappschaftskrankenhaus	Bochum
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Klinikum Grosshadern	Munich
Italy	San Gerardo Monza	Monza

Sponsors (1)

Lead Sponsor	Collaborator
Embo-Flüssigkeiten A.G.

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Score (mRS)	mRS is a scale used to measure the degree of handicap or dependence in daily activities of people who have suffered a stroke or other causes of neurological handicap.; The scale ranges from 0 to 6, running from perfect health, without symptoms, to death.; 0 - No symptoms; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Death.	3 to 6 months after the last embolisation session