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NCT05437055Completed

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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 (registry)
Completed
Study type
Interventional
Enrollment
216 (actual)
First submitted
23 Jun 2022
Start date
11 Aug 2022
Primary completion date
23 Sept 2024
Lead sponsor
Penumbra Inc.
Diseases
Stroke
NCT number
NCT05437055

What you commit to

  • Study type: Interventional
  • Participants enrolled: 216
  • From 11 Aug 2022 to the primary completion date, 23 Sept 2024
  • 32 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 illness

  • Alberta Stroke Program Early CT Score (ASPECTS) ≤6 or core infarct volume \>50 mL on MRI or CT-based imaging (for anterior circulation strokes)
  • 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

Other

  • Stenosis, excessive tortuosity, or any occlusion in a proximal vessel requiring treatment or preventing access to the thrombus
  • Pregnant patient
  • Life expectancy \< 90 days due to comorbidities

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Albany Medical Center
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AlbanyUnited StatesUnknown status
Piedmont Hospital Atlanta
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AtlantaUnited StatesUnknown status
Massachusetts General
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BostonUnited StatesUnknown status
University of Buffalo
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BuffaloUnited StatesUnknown status
MUSC
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CharlestonUnited StatesUnknown status
Geisinger Medical Center
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DanvilleUnited StatesUnknown status
HRI - Swedish
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EnglewoodUnited StatesUnknown status
North Shore U.
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EvanstonUnited StatesUnknown status
Abrazo West Campus
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GoodyearUnited StatesUnknown status
UT Houston
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HoustonUnited StatesUnknown status
Indiana U. Health
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IndianapolisUnited StatesUnknown status
St. Dominic
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JacksonUnited StatesUnknown status
KUMC
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Kansas CityUnited StatesUnknown status
Fort Sanders
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KnoxvilleUnited StatesUnknown status
Wellstar Kennestone Hospital
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MariettaUnited StatesUnknown status
Methodist U.
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MemphisUnited StatesUnknown status
Jackson Memorial (U. of Miami)
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MiamiUnited StatesUnknown status
Abbott Northwestern
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MinneapolisUnited StatesUnknown status
Edward Elmhurst Health
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NapervilleUnited StatesUnknown status
Christiana Care
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NewarkUnited StatesUnknown status
Yale New Haven
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New HavenUnited StatesUnknown status
Riverside Regional Medical Center
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Newport NewsUnited StatesUnknown status
Nebraska Medical
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OmahaUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
Valley Medical Center
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RentonUnited StatesUnknown status
Sharp Grossmont
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San DiegoUnited StatesUnknown status
Stonybrook U.
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Stony BrookUnited StatesUnknown status
St. Joseph - BayCare
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TampaUnited StatesUnknown status
Christus Trinity Medical Center
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TylerUnited StatesUnknown status
New Hanover Regional
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WilmingtonUnited StatesUnknown status
Umass Memorial Medical Center
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WorcesterUnited StatesUnknown status
Wellspan York
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YorkUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.