cerebral arteriovenous malformations
Conditions
Brief summary
Comparison between the two arms of the proportion of patients showing at least one of the following improvements at 6 months: Increase of at least 5 points in MoCA score / Reduction of at least 4 points in NIHSS score / Improvement of at least one stage in epilepsy balance score - Reduction of at least 12 points on HIT-6 headache score
Detailed description
Increase of at least 5 points in MoCA score between M0 and M6, Reduction of at least 4 points in NIHSS score between M0 and M6, Reduction of at least one stage in epilepsy balance score between M0 and M6, Reduction of at least 12 points in HIT-6 score between M0 and M6, Cerebral hemorrhage diagnosed by cerebral MRI at 6 months, Percentage reduction in diameter of AVM drainage veins between brain MRI at M0 and M6, Evolution of peri-MAV edema on brain MRI between M0 and M6 according to the following categorization: improvement, stable or worsening, Modified Rankin score (mRS) <2 at M6, Change in modified Rankin score (mRS) between M0 and M6, Change in EQ-5D-5L score from M0 to M6, All-cause mortality at 6 months, Evolution of plasma VEGF concentration between M0 and M6, MoCA, HIT-6, NIHSS and epilepsy balance scores at 12 months, mRS score at 12 months, EQ-5D-5L score at 12 months, Rate of occurrence of cerebral haemorrhage diagnosed by cerebral MRI at 12 months, Rate of occurrence of adverse events at 12 months
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between the two arms of the proportion of patients showing at least one of the following improvements at 6 months: Increase of at least 5 points in MoCA score / Reduction of at least 4 points in NIHSS score / Improvement of at least one stage in epilepsy balance score - Reduction of at least 12 points on HIT-6 headache score | — |
Secondary
| Measure | Time frame |
|---|---|
| Increase of at least 5 points in MoCA score between M0 and M6, Reduction of at least 4 points in NIHSS score between M0 and M6, Reduction of at least one stage in epilepsy balance score between M0 and M6, Reduction of at least 12 points in HIT-6 score between M0 and M6, Cerebral hemorrhage diagnosed by cerebral MRI at 6 months, Percentage reduction in diameter of AVM drainage veins between brain MRI at M0 and M6, Evolution of peri-MAV edema on brain MRI between M0 and M6 according to the following categorization: improvement, stable or worsening, Modified Rankin score (mRS) <2 at M6, Change in modified Rankin score (mRS) between M0 and M6, Change in EQ-5D-5L score from M0 to M6, All-cause mortality at 6 months, Evolution of plasma VEGF concentration between M0 and M6, MoCA, HIT-6, NIHSS and epilepsy balance scores at 12 months, mRS score at 12 months, EQ-5D-5L score at 12 months, Rate of occurrence of cerebral haemorrhage diagnosed by cerebral MRI at 12 months, Rate of occurrence of ad | — |
Countries
France