Acute Ischemic Stroke, Large Vessel Occlusion
Conditions
Keywords
Acute Ischemic Stroke, AIS, Large Vessel Occlusion, LVO, Mechanical Thrombectomy, Penumbra System, Thunderbolt Aspiration Tubing, A Direct Aspiration First Pass Technique, ADAPT
Brief summary
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.
Interventions
DEVICEMechanical Thrombectomy (Penumbra System with Thunderbolt)
Subject will receive Penumbra System with Thunderbolt
Sponsors
Penumbra Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Endpoint: Angiographic Revascularization | Immediate Post Procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Endpoint: Angiographic Revascularization After First Pass | Index Procedure | 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 |
| Efficacy Endpoint: Angiographic Revascularization | Immediate Post Procedure | 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 |
| Efficacy Endpoint: Time to Revascularization | Index Procedure | Time to Revascularization |
| Efficacy Endpoint: Modified Rankin Scale (mRS) | 90 Days Post-Procedure | Functional outcomes measured by mRS 0-2 at 90 days (0 no symptoms - 5 severe disability) |
| Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH) | 24 hours Post-Procedure | Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours |
| Safety Endpoint: All-cause mortality | 90 Days Post-Procedure | All-cause mortality at 90 days |
| Safety Endpoint: Serious Adverse Events (SAEs) | Up to 24 hours Post-Procedure | Incidence of device related, and/or procedure related Serious Adverse Events (SAEs) within 24 hours post-procedure |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDonald Frei, M.D.
HCA HealthONE, LLC (Swedish Medical Center)
PRINCIPAL_INVESTIGATORDavid Fiorella, M.D.
The Research Foundation for The State University of New York (Stony Brook University)
Outcome results
None listed