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The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Registry Objective: The primary objective of this registry is to collect real-world performance and safety data on Penumbra System including the 3D Revascularization Device in a patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).
Registry Design: This will be a prospective, single-arm, multi-center observational registry and will include patients that present with either anterior or posterior LVO who are eligible for mechanical thrombectomy using the Penumbra System.
Registry Duration: Subjects will be in the registry for approximately 90 days from enrollment to last follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with acute ischemic stroke secondary to LVO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penumbra System | Device | Penumbra System |
|
| Measure | Description | Time Frame |
|---|---|---|
| mTICI Score | Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score 2b or higher. mTICI scale ranges 0 to 3 higher values represent better outcomes. | Post Procedure |
| Functional Subject Outcome | Functional subject outcome at 90 days post-procedure as defined by a modified Rankin Scale (mRS) 0-2. mRS scale ranges 0 to 6 higher values represent a worse outcome. | 90 days post |
| All-cause mortality at 90 days | All-cause mortality at 90 days | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device and procedure related Serious Adverse Events (SAEs) | Within 24 hours of procedure | |
| Occurrence of embolization in previously uninvolved (or new) territories (ENT) | Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
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| Name | Affiliation | Role |
|---|---|---|
| Osama O Zaidat, MD | Mercy St. Vincent Medical Center | Principal Investigator |
| Johanna Fifi, MD | Mount Sinai Health System | Principal Investigator |
| Ameer E. Hassan, MD | McAllen Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Desert Medical Center | Mesa | Arizona | 85202 | United States | ||
| Eden Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37794880 | Derived | Hassan AE, Fifi JT, Zaidat OO. Aspiration thrombectomy with the Penumbra System for patients with stroke and late onset to treatment: a subset analysis of the COMPLETE registry. Front Neurol. 2023 Sep 14;14:1239640. doi: 10.3389/fneur.2023.1239640. eCollection 2023. | |
| 36016541 | Derived | Hassan AE, Zaidat OO, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Fifi JT. Impact of interhospital transfer vs. direct admission on acute ischemic stroke patients: A subset analysis of the COMPLETE registry. Front Neurol. 2022 Aug 9;13:896165. doi: 10.3389/fneur.2022.896165. eCollection 2022. |
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| During Procedure |
| Occurrence of symptomatic intracranial hemorrhages (sICH) | 24 Hours Post Procedure |
| Time to Revascularization | During Procedure |
| Length of hospital stay | Through discharge, up to study completion at approximately 90 days |
| Discharge Facility | Through discharge, up to study completion at approximately 90 days |
| Castro Valley |
| California |
| 94546 |
| United States |
| St. Jude Medical Center | Fullerton | California | 92835 | United States |
| Cedar Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Mercy San Juan Medical Center | Sacramento | California | 95608 | United States |
| Los Robles Hospital | Thousand Oaks | California | 91360 | United States |
| RIA | Englewood | Colorado | 80112 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06519 | United States |
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| Naples Community Hospital | Naples | Florida | 34102 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66106 | United States |
| Oschner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| SSM St. Clare Healthcare | St Louis | Missouri | 63026 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| Northwell Health | Manhasset | New York | 11042 | United States |
| Mount Sinai New York | New York | New York | 10029 | United States |
| NYU Langone Hospital-Brooklyn | New York | New York | 11220 | United States |
| Mercy St. Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Palmetto Health Richland Hospital | Columbia | South Carolina | 29203 | United States |
| Erlanger Health System | Chattanooga | Tennessee | 37403 | United States |
| Fort Sanders Regional Medical Center | Knoxville | Tennessee | 37916 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| Valley Baptist Medical Center | Harlingen | Texas | 78550 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| McAllen Medical Center | McAllen | Texas | 78503 | United States |
| Swedish Medical Center-Cherry Hill | Seattle | Washington | 98122 | United States |
| CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | 33000 | France |
| Foundation Ophthalmic Adolphe De Rothschild | Paris | 75019 | France |
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | 09116 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitätsklinikum Schleswig-Holstein Campus Lübeck | Lübeck | 23538 | Germany |
| Universitätsklinikum Magdeburg A. ö. R. | Magdeburg | 39120 | Germany |
| Samodzielny Publiczny Szpital Kliniczny | Lublin | 20 - 954 | Poland |
| Davidovsky Moscow City Hospital №23 | Moscow | 109240 | Russia |
| City Clinical Hospital No. 1 | Moscow | 119049 | Russia |
| Multidisciplinary City Hospital №2 | Saint Petersburg | 194354 | Russia |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clínico Universitario Virgen de la Arrixaca | Murcia | 30120 | Spain |
| 34547927 | Derived | Zaidat OO, Fifi JT, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Tekle W, Singh IP, Matouk C, Thalwitzer J, Jargiello T, Skrypnik D, Beuing O, Berge J, Katz JM, Biondi A, Bonovich D, Sheth SA, Yoo AJ, Hassan AE; COMPLETE Registry Investigators. Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results. Stroke. 2022 Mar;53(3):769-778. doi: 10.1161/STROKEAHA.121.034268. Epub 2021 Sep 22. |
| 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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