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

Not Applicable

Completed

• Conditions: Large Vessel Occlusion; Acute Ischemic Stroke
• Interventions: Device: Mechanical Thrombectomy (Penumbra System with Thunderbolt)

• Registration Number: NCT05437055
• Lead Sponsor: Penumbra Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-06-29
• Study Start: 2022-08-11
• Primary Completion: 2024-09-23
• Study Completion: 2024-12-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Mechanical Thrombectomy (Penumbra System with Thunderbolt)	Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy

Primary Outcome Measures

Name	Time	Method
Efficacy Endpoint: Angiographic Revascularization	Immediate Post Procedure	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

Secondary Outcome Measures

Name	Time	Method
Efficacy Endpoint: Angiographic Revascularization After First Pass	Index Procedure	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
Efficacy Endpoint: Angiographic Revascularization	Immediate Post Procedure	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
Efficacy Endpoint: Time to Revascularization	Index Procedure	Time to Revascularization
Efficacy Endpoint: Modified Rankin Scale (mRS)	90 Days Post-Procedure	Functional outcomes measured by mRS 0-2 at 90 days; (0 no symptoms - 5 severe disability)
Safety Endpoint: Serious Adverse Events (SAEs)	Up to 24 hours Post-Procedure	Incidence of device related, and/or procedure related Serious Adverse Events (SAEs) within 24 hours post-procedure
Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)	24 hours Post-Procedure	Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours
Safety Endpoint: All-cause mortality	90 Days Post-Procedure	All-cause mortality at 90 days

Trial Locations

Locations (32)

Abrazo West Campus; 🇺🇸 Goodyear, Arizona, United States

Sharp Grossmont; 🇺🇸 San Diego, California, United States

HRI - Swedish; 🇺🇸 Englewood, Colorado, United States

Yale New Haven; 🇺🇸 New Haven, Connecticut, United States

Christiana Care; 🇺🇸 Newark, Delaware, United States

Jackson Memorial (U. of Miami); 🇺🇸 Miami, Florida, United States

St. Joseph - BayCare; 🇺🇸 Tampa, Florida, United States

Piedmont Hospital Atlanta; 🇺🇸 Atlanta, Georgia, United States

Wellstar Kennestone Hospital; 🇺🇸 Marietta, Georgia, United States

North Shore U.; 🇺🇸 Evanston, Illinois, United States

Edward Elmhurst Health; 🇺🇸 Naperville, Illinois, United States

Indiana U. Health; 🇺🇸 Indianapolis, Indiana, United States

KUMC; 🇺🇸 Kansas City, Kansas, United States

Massachusetts General; 🇺🇸 Boston, Massachusetts, United States

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

Abbott Northwestern; 🇺🇸 Minneapolis, Minnesota, United States

St. Dominic; 🇺🇸 Jackson, Mississippi, United States

Nebraska Medical; 🇺🇸 Omaha, Nebraska, United States

Albany Medical Center; 🇺🇸 Albany, New York, United States

University of Buffalo; 🇺🇸 Buffalo, New York, United States

Stonybrook U.; 🇺🇸 Stony Brook, New York, United States

New Hanover Regional; 🇺🇸 Wilmington, North Carolina, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Wellspan York; 🇺🇸 York, Pennsylvania, United States

MUSC; 🇺🇸 Charleston, South Carolina, United States

Fort Sanders; 🇺🇸 Knoxville, Tennessee, United States

Methodist U.; 🇺🇸 Memphis, Tennessee, United States

UT Houston; 🇺🇸 Houston, Texas, United States

Christus Trinity Medical Center; 🇺🇸 Tyler, Texas, United States

Riverside Regional Medical Center; 🇺🇸 Newport News, Virginia, United States

Valley Medical Center; 🇺🇸 Renton, Washington, United States