Cerebral Arteriovenous Malformations
Conditions
Keywords
Cerebral, Arteriovenous, Malformation, Embolization, Endovascular
Brief summary
A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated.
Detailed description
This observational study will collect data about the treatment of ruptured, unruptured, untreated or endovascular previously treated AVM's. Primary endpoint is safety. Safety will be assessed with the number of procedure-related complications occurring during the endovascular treatment until 30 days after the final embolization. Secondary endpoint is efficacy. Efficacy will be assessed by angiography and clinical outcome assessments (mRS). For each patient enrolled, data will be collected at inclusion, at each embolization session and at 6 ± 1 months after the end of the endovascular treatment phase.
Interventions
DEVICESQUID™
Sponsors
Archer Research
Emboflu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient must sign the informed consent form prior to the index-procedure. If patient is unable to provide it him- or herself because of the patient's medical condition, the informed consent of the patient's legally authorized representative shall be requested. 2. The patient has an untreated or endovascular previously treated cerebral AVM for which endovascular treatment is indicated. 3. The patient is at least 18 years old.
Exclusion criteria
1. Patient is pregnant. 2. Patient with renal insufficiency (GFR \< 45 ml/min/1.73 m²)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complications / adverse events (Safety) | From the start of the procedure until 30 days after procedure | The safety is assessed with the number of procedure-related complications occurring during endovascular treatment until 30 days after the final embolization session. Procedure-related complications include complications/adverse events related to the procedure or to the device such as but not limited to hemorrhagic and ischemic complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome measurement with mRS (Efficacy) | At 6 months after the last treatment session, compared to baseline | Change of mRS score at 6 months after treatment phase is assessed compared to baseline mRS score. |
| Degree of targeted portion of AVM occlusion | 6 months | The degree of the predefined targeted portion of the AVM's occlusion will be assessed angiographically. |
Countries
Belgium, Germany
Outcome results
None listed