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

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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

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

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)

Trial contacts and locations

26

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Central trial contact

Rahsaan Holley; Brooke Lawson

Data sourced from clinicaltrials.gov

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