Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up. Information collected during the study will be standardized across centers to include pre-treatment baseline characteristics of patients including aneurysm(s) symptoms, procedural information, prespecified clinical safety events of interest, and follow-up imaging, clinical visits or telephone calls.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Complete or Stable Raymond Roy II | The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. It is also known as the Raymond class, Montreal scale or the Raymond Montreal scale | 5 year |
| Intracranial hemorrhage including SAH and IPH | Determined by adverse event adjudication by the clinical events committee | 5 year |
| All ischemic and hemorrhagic stroke | Determined by adverse event adjudication by the clinical events committee | 5 year |
| Neurological deaths | Determined by adverse event adjudication by the clinical events committee | 5 year |
| Transient Ischemic Attack | Determined by adverse event adjudication by the clinical events committee | 5 year |
| Parent artery patency | Determined by the corelab adjudication of images | 5 year |
| In-stent stenosis | Determined by the corelab adjudication of images | 5 year |
| Target aneurysm retreatment |
Not provided
Not provided
Inclusion Criteria:
The following criteria match the FDA-approved indications for use per PMA (P170013)
(Device models: 212517-LVIS, 212525-LVIS, 213015-LVIS, 213025-LVIS, 213041-LVIS, 214035-LVIS, 214049-LVIS; 212912-LVIS, 212917-LVIS, 212922-LVIS, 212928-LVIS, and 212931-LVIS);
Availability of Medical Health Records;
Subject whose age is ≥ 18;
Appropriate or Waived Consent:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population conforms to currently approved Indications for Use: Subjects with wide-necked (neck ≥ 4 mm or dome to neck ratio < 2) intracranial, saccular aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm who underwent treatment with LVIS device since approval in the local geography of researched sizes.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Microvention | Aliso Viejo | California | 92656 | United States |
Not provided
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Presented by the subject medical records
| 5 year |
| Cerebral vasospasm | Presented by the subject medical records | 5 year |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |