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An observational post-market, open label, multicenter Observatory. The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory.
Subjects will be screened for Observatory eligibility after giving informed consent. The embolization procedure will be performed in the digital angiographic suite using standard angiographic techniques.
Initial analysis of Observatory data will be performed at completion of 12 month follow-up for the first thirty-five (35) subjects.
Subjects will be followed per Institution's standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WEB Aneurysm Embolization System | Subjects aged ≥ 18 years, but ≤ 75 years requiring treatment for intracranial aneurysms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WEB Aneurysm Embolization System | Device | WEB Aneurysm Embolization System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Durability of aneurysm occlusion | The following efficacy assessments will be performed to assess the efficacy of the WEB Aneurysm Embolization System in the endovascular treatment of aneurysms. 1. Durability of occlusion compared to post-procedure imaging Durability is defined as: i. No worsening of Raymond Class from post-procedure result to follow-up result and ii. Not classified as "Recanalized" | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence/recanalization rate | Rate of aneurysm recanalization | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Raymond Scale | 12 months | |
| Percentage occlusion | 12 months |
Inclusion Criteria:
The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory
Subject must be ≥ 18 years of age;
Subject must have an intracranial aneurysm requiring treatment according to a multidisciplinary decision. If the subject has an additional aneurysm requiring treatment, the additional aneurysm must not require treatment within 30 days of the index procedure;
Aneurysm to be treated must have the following characteristics:
i. Morphology - saccular ii. Location:
Subject must be considered by the physician to be available for subsequent visits;
Subject must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule;
Subject must sign and date CPP and/or CCTIRS/CNIL approved written informed consent prior to initiation of any clinical evaluation procedures, including screening procedures (if unable to sign for self, legal representative may do so where applicable).
Additional inclusion criterion for ruptured aneurysms:
For subjects with ruptured aneurysm: subject has ruptured aneurysm with Hunt & Hess Score of I, II, or III
Exclusion Criteria:
Additional Exclusion Criteria for unruptured aneurysms:
15. Subject has Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of subarachnoid/intracranial hemorrhage on presentation; 16. Subject has any circulatory, neurovascular, or cardiovascular medical conditions that have resulted in neurological symptoms;
Additional Exclusion Criteria for ruptured aneurysms:
17. Subject has a ruptured aneurysm and Hunt & Hess Score of IV or V;
Additional Imaging Exclusion Criteria:
18. Subject has CT or MRI evidence of intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation; 19. Subject has angiographic evidence of vasculitis; 20. Microcatheter could not reach Subject's aneurysm to allow necessary access to treat with clinical evaluation device
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The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Pierot, MD PhD | CHU de Reims | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Pellegrin | Bordeaux | 33076 | France | |||
| CHU Côte de Nacre |
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| Label | URL |
|---|---|
| Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory). | View source |
| WEB Treatment of Intracranial Aneurysms: Clinical and Anatomic Results in the French Observatory. | 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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| Caen |
| 14033 |
| France |
| CHU Beaujon | Clichy | 92110 | France |
| Hôpital Neurologique Pierre Wertheimer | Lyon | 69500 | France |
| Hôpital Nord Laennec | Nantes | 44093 | France |
| CHU La Miletrie | Potiers | 86021 | France |
| CHU Reims - Hôpital Maison-Blanche | Reims | 51092 | France |
| CHU Pontchailloux | Rennes | 35033 | France |
| CHU Purpan | Toulouse | 31059 | France |
| CHU Bretonneau | Tours | 37000 | France |
| WEB Treatment of Intracranial Aneurysms: Feasibility, Complications, and 1-Month Safety Results with the WEB DL and WEB SL/SLS in the French Observatory. | View source |
| Aneurysm Treatment With Woven EndoBridge in the Cumulative Population of Three Prospective Multicenter Series: 2-Year Follow-up | View source |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |