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| Name | Class |
|---|---|
| Archer Research | INDUSTRY |
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A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebral AVM treated with SQUIDâ„¢ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SQUIDâ„¢ | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications / adverse events (Safety) | 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. | From the start of the procedure until 30 days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome measurement with mRS (Efficacy) | Change of mRS score at 6 months after treatment phase is assessed compared to baseline mRS score. | At 6 months after the last treatment session, compared to baseline |
| Degree of targeted portion of AVM occlusion |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a cerebral AVM for whom endovascular treatment is indicated.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Antwerpen | Edegem | 2650 | Belgium | |||
| Ziekenhuis Oost Limburg (ZOL) |
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| ID | Term |
|---|---|
| D002538 | Intracranial Arteriovenous Malformations |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The degree of the predefined targeted portion of the AVM's occlusion will be assessed angiographically. |
| 6 months |
| Genk |
| 3600 |
| Belgium |
| AZ Sint-Lucas | Ghent | 9000 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Alfried Krupp Krankenhaus | Essen | 45131 | Germany |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |