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This is a preliminary randomised controlled trial comparing the use of pre-operative 3D models to select an intrasaccular flow disruptor for endovascular aneurysm cure.
Patients will be randomised 3:1 either in the intervention or control group. Intervention consists of using the pre-operative Digital Subtraction Angiography (DSA) to create a 3D plastic model. This model is used to test different sizes of device. At the end of this pre-operative test a single device is recommended for the real procedure. The control group will use the current method for size selection (measurement of mean width and minimum height) on DSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With 3D anatomical model | Experimental | Surgery prepared using 3D anatomical model of the aneurysm |
|
| Without 3D anatomical model | No Intervention | Surgery prepared without 3D anatomical model of the aneurysm (routine care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D anatomical model of aneurysm | Procedure | Surgery prepared with 3D anatomical model of aneurysm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with successful procedure | Proportion of patients for which flow disruption succeeded at first intent, without any change of size required for WEB disruptor | Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume CHARBONNIER, MD | Contact | +33381668502 | g1charbonnier@chu-besancon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Guillaume CHARBONNIER, MD | CHU de Besançon | Principal Investigator |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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