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 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.
Consecutive patients planned for embolization using SQUID to achieve occlusion of a previously untreated bAVM.
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.
Exclusion Criteria:
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 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.
AVM embolization using SQUID non-adhesive liquid embolic agent
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
Plan to share: No
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