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This is a prospective, multicenter, post-market clinical follow-up (PMCF) study to collect safety and performance data in patients with arteriovenous malformations (AVMs) who undergo endovascular coil embolization using the i-ED Coil and Electro Detach Generator v4 (EDG v4).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| i-ED Coil / Electro-detach Generator v4 | Experimental | Participants with arteriovenous malformations (AVMs) will undergo endovascular coil embolization using the i-ED Coil in combination with the Electro Detach Generator v4 (EDG v4). The study will collect safety and performance data during follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Coil Embolization | Device | Endovascular embolization performed using the i-ED Coil, a detachable platinum coil system, in combination with the Electro Detach Generator v4 (EDG v4). |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedural AVM Occlusion Assessed by Angiography or MRI | Complete or partial obliteration of AVMs assessed by angiography or MRI. | 12, 36, 60 months |
| Successful Coil Embolization Assessed by Angiography | Reduced blood flow to target vessels following coil embolization, assessed by angiography. | 12, 36, 60 months |
| The Frequency of Detachment of Coils During Treatment Procedure | Frequency of successful coil detachment using the EDG v4 during the treatment procedure. | Periprocedural |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |