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

NCT03413852 | Unknown

• 1 other identifier: CIP-201701-SQUID
• Study Type: observational
• Target: 111
• Locations: 5 countries
• Sites: 19

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.

Conditions

Cerebral Arteriovenous Malformation

Outcome Measures

Primary Outcomes (1)

• 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 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Death.

  3 to 6 months after the last embolisation session

Interventions

SQUID non-adhesive liquid embolic agent DEVICE

AVM embolization using SQUID non-adhesive liquid embolic agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Embo-Flüssigkeiten A.G.: lead

Study Sites (19)

University Hospital Antwerp

Edegem, Belgium

Location

Odense University Hospital

Odense, Denmark

Location

CHU Bordeaux

Bordeaux, France

Location

CHU Brest

Brest, France

Location

Hospices Civils de Lyon

Bron, France

Location

CHU Bicêtre

Le Kremlin-Bicêtre, France

Location

Hôpital Central

Nancy, 54000, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Hôpital Maison Blanche

Reims, 51000, France

Location

CHU Rouen

Rouen, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

CHU Toulouse

Toulouse, France

Location

Zentralklinikum Augsburg

Augsburg, Germany

Location

Klinikum der Ruhr-Universität Bochum, Knappschaftskrankenhaus

Bochum, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Klinikum Grosshadern

Munich, Germany

Location

San Gerardo Monza

Monza, Italy

Location

MeSH Terms

Conditions

Intracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 29, 2018
• Study Start: May 11, 2018
• Primary Completion: March 1, 2022
• Study Completion: August 1, 2022
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); DK (1); DE (5); IT (1); FR (11)