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The objective of this study is to investgiate the safety and clinical performance of the World Diverter Emoblization Device for the endovascular treatment of wide-neck (neck width ≥ 4 mm or dome-to-neck ratio <2) or fusiform intracranial aneurysms in the internal carotid artery (ICA) from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 5.5 mm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| World Diverter Implantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flow diverter implantation | Device | Implantation of the World Diverter Embolization Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety - Major Adverse Events (MAEs) | Composite incidence of the following events:
| 12 months |
| Primary Effectiveness - Complete Occlusion | The proportion of subjects with all of the following:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medium-Term Effectiveness | Complete IA occlusion | 6 months |
| Medium-Term Parent Artery Stenosis | Parent Artery Stenosis | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Angiographic Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro Tomasello, MD | Hospital Vall d'Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
Individual participant data are protected by data privacy laws and are only provided for the purposes of this study following provision of participant informed consent.
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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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| Medium-Term Functional Outcomes | Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline | 6 months |
| Secondary Effectiveness - Adequate Occlusion | The proportion of subjects with all of the following:
| 12 months |
| Long-Term Angiographic Outcome | Raymond-Roy IA classifications | 12 months |
| Long-Term Parent Artery Stenosis | Parent Artery Stenosis | 12 months |
| Long-Term Functional Outcome | Modified Rankin Score (0-6, 0=no symptoms, 6=dead) compared to baseline | 12 months |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |