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International, non-randomized, European , multicenter, observational study to collect data for the treatment of intracranial aneurysms with OPTIMA coils system to further document its safety and efficacy
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intracranial aneurysm coiling | Device | endovascular treatment of intracranial aneurysm by coiling procedure using OPTIMA coils system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morbi-mortality at 30 days | Rate of adverse events including thromboembolic events, the bleeding/rebleeding episodes, the rate of retreated aneurysm and the rate of mortality occurring during the procedure and up to 30 days. | 30 days |
| Clinical outcomes (mRS) at 30 days | Classification of the patient clinical and neurological outcomes based on modified Rankin Scale from 0 (no symptoms a all) to 6 (dead). Global outcomes of mRS 0-2 are considered good and those of mRS 3-6 (including mRS 6 - deceased) are considered to be poor. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Morbi-mortality at 12 months | Rate of adverse events including thromboembolic events, the bleeding/rebleeding episodes, the rate of retreated aneurysm and the rate of mortality occurring within 12 months after the procedure. | 12 months |
| Clinical outcomes (mRS) at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck | Innsbruck | A-6020 | Austria | |||
| CHU de Bordeaux - Hôpital Pellegrin |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Classification of the patient clinical and neurological outcomes based on modified Rankin Scale from 0 (no symptoms a all) to 6 (dead). Global outcomes of mRS 0-2 are considered good and those of mRS 3-6 (including mRS 6 - deceased) are considered to be poor. |
| 12 months |
| Aneurysm occlusion rate | Post-procedure and 12-month follow-up efficacy based on the assessment of the aneurysm occlusion rate according to the 3-grade Montreal scale (complete occlusion/neck remnant/aneurysm remnant). | Up to 24h and 12 months |
| Bordeaux |
| 33000 |
| France |
| CHU de Brest - Hôpital La Cavale Blanche | Brest | 29200 | France |
| Hospices Civils de Lyon - Hôpital Neurologique | Bron | 69677 | France |
| CHU Côte de Nâcre | Caen | 14000 | France |
| Hôpital Privé Clairval | Marseille | 13009 | France |
| CHU Gui de Chaulliac | Montpellier | Costalat | France |
| CHU Hôpital Maison Blanche | Reims | 51000 | France |
| CHU Charles-Nicolle | Rouen | 76000 | France |
| CHRU Strasbourg Hautepierre | Strasbourg | 67200 | France |
| Zentralklinikum Augsburg | Augsburg | 86156 | Germany |
| Azienda Ospedallera | Catania | 95126 | Italy |
| San Gerardo Hospital | Monza | 20900 | Italy |
| Antonio Cardarelli Hospital | Naples | 80131 | Italy |
| ULSS8 Berica Ospedale San Bortolo | Vicenza | 36100 | Italy |
| University of Latvia, Faculty of Medicine | Riga | Latvia |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital: Fundacion Jimenez Diaz | Madrid | 28222 | Spain |
| Hospital: Puerta de Hierro | Madrid | 28222 | Spain |
| HUG Hôpital cantonal universitaire de geneva | Geneva | CH-1211 | Switzerland |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |