Status:
UNKNOWN
Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent (CHOICE)
Lead Sponsor:
Embo-Flüssigkeiten A.G.
Conditions:
Cerebral Arteriovenous Malformation
Eligibility:
All Genders
18+ years
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 strateg...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 11 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT03413852
Start Date
May 11 2018
End Date
August 1 2022
Last Update
April 30 2021
Active Locations (19)
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1
University Hospital Antwerp
Edegem, Belgium
2
Odense University Hospital
Odense, Denmark
3
CHU Bordeaux
Bordeaux, France
4
CHU Brest
Brest, France