CClinicalTrials.gg
Status unknownNCT03413852CHOICEUpdated Apr 30, 2021

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

An observational study in Cerebral Arteriovenous Malformation, sponsored by Embo-Flüssigkeiten A.G.. Status unknown at 19 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-30.

Sponsored by Embo-Flüssigkeiten A.G. · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
111
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
111 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • DeviceSQUID non-adhesive liquid embolic agent

    AVM embolization using SQUID non-adhesive liquid embolic agent

05

What researchers measure

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.

    Time frame: 3 to 6 months after the last embolisation session

06

Study locations

19 sites
  • University Hospital Antwerp
    Edegem, Belgium
  • Odense University Hospital
    Odense, Denmark
  • CHU Bordeaux
    Bordeaux, France
  • CHU Brest
    Brest, France
  • Hospices Civils de Lyon
    Bron, France
  • CHU Bicêtre
    Le Kremlin-Bicêtre, France
  • Hôpital Central
    Nancy, 54000, France
  • Hôpital Lariboisière
    Paris, 75010, France
  • Fondation Ophtalmologique Adolphe de Rothschild
    Paris, 75019, France
  • Hôpital Maison Blanche
    Reims, 51000, France
  • CHU Rouen
    Rouen, France
  • CHU de Saint-Etienne
    Saint-Étienne, 42000, France
  • CHU Toulouse
    Toulouse, France
  • Zentralklinikum Augsburg
    Augsburg, Germany
  • Klinikum der Ruhr-Universität Bochum, Knappschaftskrankenhaus
    Bochum, Germany
  • Universitätsklinikum Freiburg
    Freiburg, 79106, Germany
  • Universitätsklinikum Heidelberg
    Heidelberg, Germany
  • Klinikum Grosshadern
    Munich, Germany
  • San Gerardo Monza
    Monza, Italy
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03413852
Lead sponsor
Embo-Flüssigkeiten A.G.
Responsible party
Sponsor
First posted
Jan 29, 2018
Start date
May 11, 2018
Primary completion
Mar 2022 (estimated)
Completion
Aug 2022 (estimated)
Last update
Apr 30, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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