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

Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent - The CHOICE Study A Non-interventional, Prospective, Single-arm, International, Multicenter Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Arteriovenous Malformation
• Intervention / Treatment: Device: SQUID non-adhesive liquid embolic agent

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium
    • University Hospital Antwerp
• Denmark
  • Odense, Denmark
    • Odense University Hospital
• France
  • Bordeaux, France
    • CHU Bordeaux
  • Brest, France
    • CHU Brest
  • Bron, France
    • Hospices Civils de Lyon
  • Le Kremlin-Bicêtre, France
    • CHU Bicêtre
  • Nancy, France, 54000
    • Hôpital Central
  • Paris, France, 75010
    • Hôpital Lariboisière
  • Paris, France, 75019
    • Fondation Ophtalmologique Adolphe de Rothschild
  • Reims, France, 51000
    • Hôpital Maison Blanche
  • Rouen, France
    • CHU Rouen
  • Saint-Étienne, France, 42000
    • CHU DE SAINT-ETIENNE
  • Toulouse, France
    • CHU Toulouse
• Germany
  • Augsburg, Germany
    • Zentralklinikum Augsburg
  • Bochum, Germany
    • Klinikum der Ruhr-Universität Bochum, Knappschaftskrankenhaus
  • Freiburg, Germany, 79106
    • Universitatsklinikum Freiburg
  • Heidelberg, Germany
    • Universitätsklinikum Heidelberg
  • Munich, Germany
    • Klinikum Großhadern
• Italy
  • Monza, Italy
    • San Gerardo Monza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients planned for embolization using SQUID to achieve occlusion of a previously untreated bAVM.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Embo-Flüssigkeiten A.G.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2018
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Cardiovascular Abnormalities; Neoplasms, Vascular Tissue; Nervous System Malformations; Vascular Malformations; Intracranial Arterial Diseases; Central Nervous System Vascular Malformations; Congenital Abnormalities; Hemangioma; Arteriovenous Malformations; Intracranial Arteriovenous Malformations
• Other Study ID Numbers: CIP-201701-SQUID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No