Cerebral Arteriovenous MalformationCHOICENCT03413852
Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent (CHOICE)
An observational study of Cerebral Arteriovenous Malformation, run by Embo-Flüssigkeiten A.G. at 19 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Arteriovenous Malformation
- What is being tested?
- SQUID non-adhesive liquid embolic agent
- Type of treatment
- Medical device
- How many people
- 111 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 11 May 2018to Aug 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients planned for embolization using SQUID to achieve occlusion of a previously untreated bAVM.
Who may be able to join
- 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
Who cannot join
- 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*.
Show all 12Show fewer
- 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.
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
France11 sites
CHU Bordeaux
Bordeaux
CHU Brest
Brest
Hospices Civils de Lyon
Bron
CHU Bicêtre
Le Kremlin-Bicêtre
Hôpital Central
Nancy, 54000
Hôpital Lariboisière
Paris, 75010
Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
Hôpital Maison Blanche
Reims, 51000
CHU Rouen
Rouen
CHU de Saint-Etienne
Saint-Etienne, 42000
CHU Toulouse
Toulouse
Germany5 sites
Zentralklinikum Augsburg
Augsburg
Klinikum der Ruhr-Universität Bochum, Knappschaftskrankenhaus
Bochum
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Universitätsklinikum Heidelberg
Heidelberg
Klinikum Grosshadern
Munich
About this study
Official title: 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.
- Conditions
- Cerebral Arteriovenous Malformation
- Being tested
- SQUID non-adhesive liquid embolic agent
- Medical subject headings
- Intracranial Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQUID non-adhesive liquid embolic agentDevice
AVM embolization using SQUID non-adhesive liquid embolic agent
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 to 6 months after the last embolisation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start11 May 2018
- Primary completionMar 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Arteriovenous MalformationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Embo-Flüssigkeiten A.G.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413852
- Sponsor's protocol ID
- CIP-201701-SQUID
- Acronym
- CHOICE
- Status last verified
- Apr 2021
- First submitted
- 23 Jan 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spelle L, Gal G, Barreau X, Houdart E, Mohlenbruch MA, Gentric JC, Papagiannaki C, Piotin M, Defreyne L, Trystram D, Bonafe A, Caroff J, Cognard C; CHOICE Investigators. SQUID embolization for cerebral AVMs: 1-year safety and efficacy results from the CHOICE prospective multicenter study. J Neurointerv Surg. 2026 Jul 3:jnis-2026-025273. doi: 10.1136/jnis-2026-025273. Online ahead of print.
PubMed 42399096
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent - The CHOICE Study A Non-interventional, Prospective, Single-arm, International, Multicenter Study
- ClinicalTrials.gov ID
- NCT03413852
- Acronym / sponsor ID
- CHOICE / CIP-201701-SQUID
- Conditions
- Cerebral Arteriovenous Malformation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Embo-Flüssigkeiten A.G.Industry (pharma, biotech, devices)
- Study start
- 11 May 2018 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients planned for embolization using SQUID to achieve occlusion of a previously untreated bAVM.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SQUID non-adhesive liquid embolic agentAVM embolization using SQUID non-adhesive liquid embolic agent | Device | – |
Primary outcome
modified Rankin Score (mRS)
Time frame: 3 to 6 months after the last embolisation session
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 42399096Spelle L, Gal G, Barreau X, Houdart E, Mohlenbruch MA, Gentric JC, Papagiannaki C, Piotin M, Defreyne L, Trystram D, Bonafe A, Caroff J, Cognard C; CHOICE Investigators. SQUID embolization for cerebral AVMs: 1-year safety and efficacy results from the CHOICE prospective multicenter study. J Neurointerv Surg. 2026 Jul 3:jnis-2026-025273. doi: 10.1136/jnis-2026-025273. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Arteriovenous Malformation, run by Embo-Flüssigkeiten A.G. at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Germany, Belgium, Denmark, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Score (mRS) (time frame: 3 to 6 months after the last embolisation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03413852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.