Q28.2 I77.0
Conditions
Interventions
Group 1: Embolization according to the standard clinical procedure using the investigational device as the embolic agent (one or several sessions as needed)
Sponsors
Iberhospitex, S.A.
Eligibility
Sex/Gender
All
Age
10 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients and/or legal representative signing the informed consent form, indicating an understanding of the study protocol requirements and a willingness to participate in the study - Patients with ruptured or unruptured AVMs with predictive factors for cerebral hemorrhage and candidates for treatment by percutaneous embolization
Exclusion criteria
Exclusion criteria: - Patients planned to receive surgery after the first embolization session - Have other incompatibilities that prevent participation in the study (for example: be participating in another clinical trial at the same time) - Pregnant or lactating women - Patients with mRS = 3, 4, 5, 6 - Patients with known allergies to components according to contraindications (DMSO, iodine) - Patients with significant hepatic, thyroid or renal dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: Rate of total volume reduction at 3-6 months Co-primary composite safety endpoint: Percentage of patient with i) death, ii) stroke or iii) disabling deficit (mRS=3,4,5) after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Loss of radiopacity, presence of artifacts previous sessions (follow-up at 45 days and 3 months) | — |
Countries
Germany, Spain
Contacts
Public ContactMontserrat Gambus
Iberhospitex, S.A.
Outcome results
None listed