Arteriovenous Fistula
Conditions
Keywords
dAVF, Arteriovenous fistula, ONYX
Brief summary
The objective of this study is to evaluate the safety and performance post last embolization with Onyx
Interventions
None listed
Sponsors
Medtronic Neurovascular Clinical Affairs
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* The patient has an intracranial dAVF which could be treated by ONYX embolization, whether or not associated to other embolization products. * The patient is at least 18 years of age.
Exclusion criteria
* The patient needs to be treated for the dAVF with another treatment option (for example by surgery) than embolization within a period of less than 6 months (to be counted as from the first treatment) * The patient participates to another clinical study during the treatment period for his/her dAVF, evaluating another medical devices, procedure or medication. * The patient refuses to give consent to the collection and processing of data required for centralized monitoring. * A condition which could jeopardize follow-up of the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurological clinical evolution | 1Month post procedure | Improved, Stable, Worsened, death |
| Healing rate | 3-6 months post procedure | Number of patients with No residual early venous return |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | 3-6 months after procedure | The number of adverse events (causing death or otherwise) |
| Quality of life EQ-5D | pre-procedure and at 3-6 months | Health State Score increase |
| Describe functional independence | 1 and 12 months after procedure | Describe mRS scores assessed by a certified physician |
| Technical performance of the product | 12 months after procedure | Volume injected per embolization session |
Countries
France
Outcome results
None listed