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
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Albany Medical Center Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Piedmont Hospital Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Massachusetts General Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Buffalo Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| MUSC Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| HRI - Swedish Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| North Shore U. Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
| Abrazo West Campus Coordinator of this site? Confirm its status | Goodyear | United States | Unknown status |
| UT Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana U. Health Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| St. Dominic Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| KUMC Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Fort Sanders Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Wellstar Kennestone Hospital Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Methodist U. Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Jackson Memorial (U. of Miami) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Abbott Northwestern Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Edward Elmhurst Health Coordinator of this site? Confirm its status | Naperville | United States | Unknown status |
| Christiana Care Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Yale New Haven Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Riverside Regional Medical Center Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| Nebraska Medical Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Valley Medical Center Coordinator of this site? Confirm its status | Renton | United States | Unknown status |
| Sharp Grossmont Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Stonybrook U. Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
| St. Joseph - BayCare Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Christus Trinity Medical Center Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| New Hanover Regional Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Umass Memorial Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
| Wellspan York Coordinator of this site? Confirm its status | York | United States | Unknown status |
Related publications
- Thunderbolt System for acute ischemic stroke secondary to large vessel occlusion: primary results of the THUNDER study.J Neurointerv Surg · 2026 · PMID 42562636
This page is information, not medical advice. Discuss any trial with your doctor.