Acute Ischemic Stroke Clinical Trial
Official title:
THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderboltâ„¢ Aspiration Tubing
NCT number | NCT05437055 |
Other study ID # | 21340 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 11, 2022 |
Est. completion date | June 2025 |
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.
Status | Recruiting |
Enrollment | 275 |
Est. completion date | June 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Patient age 18 - 80 years 2. Treatment within 8 hours of symptom onset 3. Pre-stroke mRS 0-2 4. Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion in the internal carotid, middle cerebral (M1 or M2), basilar, or vertebral artery 5. If patient is eligible for thrombolytic therapy, it was administered as soon as possible, and no later than 3 hours from stroke symptom onset 6. Planned frontline treatment with Penumbra System including Thunderbolt modulated aspiration 7. Informed consent obtained per Institution Review Board/Ethics Committee requirements Exclusion Criteria: 1. Stenosis, excessive tortuosity, or any occlusion in a proximal vessel requiring treatment or preventing access to the thrombus 2. Alberta Stroke Program Early CT Score (ASPECTS) =6 or core infarct volume >50 mL on MRI or CT-based imaging (for anterior circulation strokes) 3. Pregnant patient 4. Life expectancy < 90 days due to comorbidities 5. Current participation in an interventional drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies 6. Other medical, behavioral, or psychological conditions that in the opinion of the Investigator could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study |
Country | Name | City | State |
---|---|---|---|
United States | Albany Medical Center | Albany | New York |
United States | Piedmont Hospital Atlanta | Atlanta | Georgia |
United States | Massachusetts General | Boston | Massachusetts |
United States | University of Buffalo | Buffalo | New York |
United States | MUSC | Charleston | South Carolina |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | HRI - Swedish | Englewood | Colorado |
United States | North Shore U. | Evanston | Illinois |
United States | UT Houston | Houston | Texas |
United States | Indiana U. Health | Indianapolis | Indiana |
United States | KUMC | Kansas City | Kansas |
United States | Fort Sanders | Knoxville | Tennessee |
United States | Wellstar Kennestone Hospital | Marietta | Georgia |
United States | Methodist U. | Memphis | Tennessee |
United States | Jackson Memorial (U. of Miami) | Miami | Florida |
United States | Abbott Northwestern | Minneapolis | Minnesota |
United States | Edward Elmhurst Health | Naperville | Illinois |
United States | Yale New Haven | New Haven | Connecticut |
United States | Christiana Care | Newark | Delaware |
United States | Riverside Regional Medical Center | Newport News | Virginia |
United States | Nebraska Medical | Omaha | Nebraska |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Valley Medical Center | Renton | Washington |
United States | Sharp Grossmont | San Diego | California |
United States | Stonybrook U. | Stony Brook | New York |
United States | St. Joseph - BayCare | Tampa | Florida |
United States | Christus Trinity Medical Center | Tyler | Texas |
United States | UMass Memorial Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Penumbra Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH) | Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours | 24hrs Post-Procedure | |
Secondary | 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 | |
Secondary | Efficacy Endpoint: Angiographic Revascularization | 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 | |
Secondary | Efficacy Endpoint: Time to Revascularization | Time to Revascularization | Index Procedure | |
Secondary | 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 | |
Secondary | Safety Endpoint: All-cause mortality | All-cause mortality at 90 days | 90 Days Post-Procedure | |
Secondary | 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 24hrs Post-Procedure |
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