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| Name | Class |
|---|---|
| ClinSearch | OTHER |
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This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ED Coil / Electro-detach Generator v4 | Device | The ED Coil is used for vascular embolization with a platinum coil at the target lesion in a patient's blood vessel. The ED Detach Generator is intended to for use solely to detach the platinum coil from the delivery catheter of the ED Coil. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance Measure | The recanalization in aneurysms will be classified using the Raymond-Roy Classification. The outcomes following embolization of arteriovenous malformations and arteriovenous fistula will be classified as follows complete occlusion/subtotal occlusion/ partial occlusion | At 6 months |
| Performance Measure | The recanalization in aneurysms will be classified using the Raymond-Roy Classification. The outcomes following embolization of arteriovenous malformations and arteriovenous fistula will be classified as follows complete occlusion/subtotal occlusion/ partial occlusion | At 12 months |
| Safety Measure - Assessment of Adverse Events | All adverse events will be recorded, along with their seriousness and relatedness to the device or the procedure. | During 12 months |
| Technical Measure | The technical properties of the ED Electrodetach Generator v4 will be assessed by successful coil detachment (yes/no) | At embolization procedure, an average of 1 week |
| Technical Measure | The technical properties of the ED Electrodetach Generator v4 will be assessed by the the number of detachment attempts | At embolization procedure, an average of 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with an aneurysm, arteriovenous malformation, or arteriovenous fistula and eligible for endovascular treatment with ED Coil and ED Detach Generator v4.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZA Atwerp | Not yet recruiting | Edegem | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D001165 | Arteriovenous Malformations |
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
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| Knappschaftskrankenhaus Bochum | Recruiting | Bochum | North Rhine-Westphalia | 44892 | Germany |
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| Universitätsklinikum Schleswig-Holstein | Recruiting | Lübeck | Schleswig-Holstein | 23538 | Germany |
|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016157 | Vascular Fistula |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |