THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing

Study Overview
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Brief Summary
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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.

Official Title
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THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing

Conditions
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Acute Ischemic Stroke, Large Vessel Occlusion

Intervention / Treatment
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* Device: Mechanical Thrombectomy (Penumbra System with Thunderbolt)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age 18 - 80 years Treatment within 8 hours of symptom onset Pre-stroke mRS 0-2 Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion in the internal carotid, middle cerebral (M1 or M2), basilar, or vertebral artery If patient is eligible for thrombolytic therapy, it was administered as soon as possible, and no later than 3 hours from stroke symptom onset Planned frontline treatment with Penumbra System including Thunderbolt modulated aspiration Informed consent obtained per Institution Review Board/Ethics Committee requirements Exclusion Criteria: Stenosis, excessive tortuosity, or any occlusion in a proximal vessel requiring treatment or preventing access to the thrombus Alberta Stroke Program Early CT Score (ASPECTS) ≤6 or core infarct volume >50 mL on MRI or CT-based imaging (for anterior circulation strokes) Pregnant patient Life expectancy < 90 days due to comorbidities 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy | Device: Mechanical Thrombectomy (Penumbra System with Thunderbolt)<br>* Subject will receive Penumbra System with Thunderbolt<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH) | Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours | 24hrs Post-Procedure | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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: 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 24hrs Post-Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Ischemic Stroke, AIS, Large Vessel Occlusion, LVO, Mechanical Thrombectomy, Penumbra System, Thunderbolt Aspiration Tubing, A Direct Aspiration First Pass Technique, ADAPT