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A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS® device in the treatment of wide necked intracranial aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVIS® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVIS® | Device | Low-profile Visualized Intraluminal Support device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm | 6 months | |
| Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm | 18 months | |
| Retreatment rate | 6 months | |
| Retreatment rate | 18 months | |
| Morbidity rate | 6 months | |
| Morbidity rate | 18 months | |
| Mortality rate | 6 months | |
| Mortality rate | 18 months |
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Inclusion Criteria:
Patient or patient's legally authorized representative has been informed about the confidentiality of the study and has agreed to the collection of his/her personal data
Patient has a ruptured or unruptured intracranial aneurysm for which:
Patient is aged ≥ 18 years
Patient presents with a WFNS score between 0 and 3
Patient has agreed to attend follow-up appointments
Exclusion Criteria:
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Patients aged minimum of 18 years with an intracranial aneurysm in whom stent-assisted coiling has been determined to be the appropriate treatment strategy.
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| Name | Affiliation | Role |
|---|---|---|
| Charbel Mounayer, Prof. | CHU Limoges; Limoges, France | Principal Investigator |
| Michel Piotin, M.D. | Fondation Rothschild; Paris, France | Principal Investigator |
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| Label | URL |
|---|---|
| Safety and effectiveness of the Low Profile Visualized Intraluminal Support (LVIS and LVIS Jr) devices in the endovascular treatment of intracranial aneurysms: results of the TRAIL multicenter observational study | View source |
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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 |
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |