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The primary objective of this study is to collect real-world performance and safety data on the Penumbra System in a patient population with acute ischemic stroke (AIS)
Post-market, real-world, prospective, single-arm, multi-center study that will enroll up to 200 participants at up to 15 sites globally
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with acute ischemic stroke (AIS) | Device: Penumbra System® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penumbra System ® | Device | Neurovacular Mechanical Thrombectomy with the Penumbra System® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Outcomes: | Angiographic revascularization of the occluded target vessel immediately post- procedure as defined by modified Thrombolysis in Cerebral Infarction (mTICI) 2b or higher Angiographic revascularization of the occluded target vessel immediately post- procedure as defined by mTICI 2c or higher
| It is anticipated this study will take approximately 2 years. All participants will be followed for approximately 90-day or to outcome (e.g., withdrawal, death), whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting with acute ischemic stroke (AIS) who are eligible for aspiration based mechanical thrombectomy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celina Wang | Contact | +49 175 1938 209 | cwang1@penumbrainc.com | |
| Egon Wülfert | Contact | +32 470 032 028 | ewuelfert@penumbrainc.com |
| Name | Affiliation | Role |
|---|---|---|
| Marios Nikos Psychogios, Prof MD | University Hospital of Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Charles Gairdner Hospital | Recruiting | Nedlands | Western Australia | 6009 | Australia |
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| CHU de Bordeaux - Hôpital Pellegrin | Recruiting | Bordeaux | 33000 | France |
|
| CHU de Brest - Hôpital de la Cavale Blanche | Recruiting | Brest | 29200 | France |
|
| Hôpital Pierre-Paul Riquet | Recruiting | Toulouse | 31300 | France |
|
| TUM Klinikum rechts der Isar | Recruiting | München | Bavaria | 81675 | Germany |
|
| Knappschaft Kliniken Vest Recklinghausen | Recruiting | Recklinghausen | Westphalia | 45657 | Germany |
|
| Universitätsklinikum Augsburg | Recruiting | Augsburg | 86156 | Germany |
|
| Universitätsklinikum Schleswig-Holstein (UKSH) Lübeck | Recruiting | Lübeck | 23538 | Germany |
|
| Universitätsspital Basel | Recruiting | Basel | Basel-Landschaft | 4031 | Switzerland |
|
| Inselspital Universitätsklinik für Neurologie | Recruiting | Bern | 3006 | Switzerland |
|
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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