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The objective of this study is to demonstrate the safety and efficacy of the Penumbra System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical Thrombectomy (Penumbra System with Thunderbolt) | Device | Subject will receive Penumbra System with Thunderbolt |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint: Angiographic Revascularization | Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by mTICI 2b or higher. *mTICI ranges from 0-3, with higher grading representing better outcome | Immediate Post Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint: Angiographic Revascularization After First Pass | Angiographic revascularization of the occluded target vessel after first pass as defined by mTICI 2b or higher *mTICI ranges from 0-3, with higher grading representing better outcome | Index Procedure |
| Efficacy Endpoint: Angiographic Revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Frei, M.D. | HCA HealthONE, LLC (Swedish Medical Center) | Principal Investigator |
| David Fiorella, M.D. | The Research Foundation for The State University of New York (Stony Brook University) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abrazo West Campus | Goodyear | Arizona | 85395 | United States | ||
| Sharp Grossmont |
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Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by mTICI 2c or higher *mTICI ranges from 0-3, with higher grading representing better outcome |
| Immediate Post Procedure |
| Efficacy Endpoint: Time to Revascularization | Time to Revascularization | Index Procedure |
| Efficacy Endpoint: Modified Rankin Scale (mRS) | Functional outcomes measured by mRS 0-2 at 90 days (0 no symptoms - 5 severe disability) | 90 Days Post-Procedure |
| Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH) | Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours | 24 hours Post-Procedure |
| Safety Endpoint: All-cause mortality | All-cause mortality at 90 days | 90 Days Post-Procedure |
| Safety Endpoint: Serious Adverse Events (SAEs) | Incidence of device related, and/or procedure related Serious Adverse Events (SAEs) within 24 hours post-procedure | Up to 24 hours Post-Procedure |
| San Diego |
| California |
| 92123 |
| United States |
| HRI - Swedish | Englewood | Colorado | 80113 | United States |
| Yale New Haven | New Haven | Connecticut | 06520 | United States |
| Christiana Care | Newark | Delaware | 19718 | United States |
| Jackson Memorial (U. of Miami) | Miami | Florida | 33136 | United States |
| St. Joseph - BayCare | Tampa | Florida | 33614 | United States |
| Piedmont Hospital Atlanta | Atlanta | Georgia | 30309 | United States |
| Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | United States |
| North Shore U. | Evanston | Illinois | 60201 | United States |
| Edward Elmhurst Health | Naperville | Illinois | 60540 | United States |
| Indiana U. Health | Indianapolis | Indiana | 46202 | United States |
| KUMC | Kansas City | Kansas | 66160 | United States |
| Massachusetts General | Boston | Massachusetts | 02114 | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Abbott Northwestern | Minneapolis | Minnesota | 55427 | United States |
| St. Dominic | Jackson | Mississippi | 39216 | United States |
| Nebraska Medical | Omaha | Nebraska | 68198 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| University of Buffalo | Buffalo | New York | 14203 | United States |
| Stonybrook U. | Stony Brook | New York | 11794 | United States |
| New Hanover Regional | Wilmington | North Carolina | 28401 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Wellspan York | York | Pennsylvania | 17403 | United States |
| MUSC | Charleston | South Carolina | 29425 | United States |
| Fort Sanders | Knoxville | Tennessee | 37916 | United States |
| Methodist U. | Memphis | Tennessee | 38104 | United States |
| UT Houston | Houston | Texas | 77030 | United States |
| Christus Trinity Medical Center | Tyler | Texas | 75702 | United States |
| Riverside Regional Medical Center | Newport News | Virginia | 23601 | United States |
| Valley Medical Center | Renton | Washington | 98055 | United States |
| 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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