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Acute Ischemic StrokeNCT05437055

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

A study testing Mechanical Thrombectomy (Penumbra System with Thunderbolt) in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Penumbra Inc. at 32 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Ischemic Stroke, Large Vessel Occlusion
What is being tested?
Mechanical Thrombectomy (Penumbra System with Thunderbolt)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
32 sitesUnited States
Study dates
11 Aug 2022to 10 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

32 sites in 1 country.

32 sites in 1 country

United States32 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Piedmont Hospital Atlanta

    Atlanta, Georgia, 30309

  • Massachusetts General

    Boston, Massachusetts, 02114

  • University of Buffalo

    Buffalo, New York, 14203

  • MUSC

    Charleston, South Carolina, 29425

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • HRI - Swedish

    Englewood, Colorado, 80113

  • North Shore U.

    Evanston, Illinois, 60201

  • Abrazo West Campus

    Goodyear, Arizona, 85395

  • UT Houston

    Houston, Texas, 77030

  • Indiana U. Health

    Indianapolis, Indiana, 46202

  • St. Dominic

    Jackson, Mississippi, 39216

  • KUMC

    Kansas City, Kansas, 66160

  • Fort Sanders

    Knoxville, Tennessee, 37916

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Methodist U.

    Memphis, Tennessee, 38104

  • Jackson Memorial (U. of Miami)

    Miami, Florida, 33136

  • Abbott Northwestern

    Minneapolis, Minnesota, 55427

  • Edward Elmhurst Health

    Naperville, Illinois, 60540

  • Yale New Haven

    New Haven, Connecticut, 06520

  • Christiana Care

    Newark, Delaware, 19718

  • Riverside Regional Medical Center

    Newport News, Virginia, 23601

  • Nebraska Medical

    Omaha, Nebraska, 68198

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Valley Medical Center

    Renton, Washington, 98055

  • Sharp Grossmont

    San Diego, California, 92123

  • Stonybrook U.

    Stony Brook, New York, 11794

  • St. Joseph - BayCare

    Tampa, Florida, 33614

  • Christus Trinity Medical Center

    Tyler, Texas, 75702

  • New Hanover Regional

    Wilmington, North Carolina, 28401

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

  • Wellspan York

    York, Pennsylvania, 17403

Other trials in United States

About this study

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.

Being tested
Mechanical Thrombectomy (Penumbra System with Thunderbolt)
Keywords
Acute Ischemic Stroke, AIS, Large Vessel Occlusion, LVO, Mechanical Thrombectomy, Penumbra System, Thunderbolt Aspiration Tubing, A Direct Aspiration First Pass Technique, ADAPT
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mechanical Thrombectomy (Penumbra System with Thunderbolt)Device

    Subject will receive Penumbra System with Thunderbolt

Study groups in NCT05437055
Study groupRoleWhat they receive
Single ArmExperimentalUse of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy
Receives: Device: Mechanical Thrombectomy (Penumbra System with Thunderbolt)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Immediate Post Procedure

Secondary outcomes (7)

  1. 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

    Measured: Index Procedure

  2. 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

    Measured: Immediate Post Procedure

  3. Efficacy Endpoint: Time to Revascularization

    Time to Revascularization

    Measured: Index Procedure

  4. Efficacy Endpoint: Modified Rankin Scale (mRS)

    Functional outcomes measured by mRS 0-2 at 90 days

    (0 no symptoms - 5 severe disability)

    Measured: 90 Days Post-Procedure

  5. Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)

    Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours

    Measured: 24 hours Post-Procedure

  6. Safety Endpoint: All-cause mortality

    All-cause mortality at 90 days

    Measured: 90 Days Post-Procedure

  7. Safety Endpoint: Serious Adverse Events (SAEs)

    Incidence of device related, and/or procedure related Serious Adverse Events (SAEs) within 24 hours post-procedure

    Measured: Up to 24 hours Post-Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2022
  2. Study start11 Aug 2022
  3. Primary completion23 Sep 2024
  4. Study completion10 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05437055
Sponsor's protocol ID
21340
Status last verified
Jun 2026
First submitted
23 Jun 2022
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Fiorella D, Woodward K, Matouk C, Levy EI, Kaminsky I, Reuland KS, Nickele C, Ammirati G, Starke RM, Ares WJ, Nahhas M, Mahapatra A, Sultan-Qurraie A, Bohnstedt B, Paul AR, Frei D. Thunderbolt System for acute ischemic stroke secondary to large vessel occlusion: primary results of the THUNDER study. J Neurointerv Surg. 2026 Aug 6:jnis-2026-025894. doi: 10.1136/jnis-2026-025894. Online ahead of print.

    PubMed 42562636

Questions about this trial

What is this clinical trial studying?

A study testing Mechanical Thrombectomy (Penumbra System with Thunderbolt) in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Penumbra Inc. at 32 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Endpoint: Angiographic Revascularization (time frame: Immediate Post Procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05437055, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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Clinical Trial NCT05437055 | AzTrials