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

Penumbra

Status: Enrolling

Conditions: Large Vessel Occlusion; Acute Ischemic Stroke

Treatments: Device: Mechanical Thrombectomy (Penumbra System with Thunderbolt)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05437055

21340

Details and patient eligibility

About

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.

Enrollment: 275 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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275 participants in 1 patient group

Single Arm

Experimental group

Description:

Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy

Treatment:

Device: Mechanical Thrombectomy (Penumbra System with Thunderbolt)