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

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke; Large Vessel Occlusion
• Intervention / Treatment: Device: Mechanical Thrombectomy (Penumbra System with Thunderbolt)

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Goodyear, Arizona, United States, 85395
      • Abrazo West Campus
  • California
    • San Diego, California, United States, 92123
      • Sharp Grossmont
  • Colorado
    • Englewood, Colorado, United States, 80113
      • HRI - Swedish
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care
  • Florida
    • Miami, Florida, United States, 33136
      • Jackson Memorial (U. of Miami)
    • Tampa, Florida, United States, 33614
      • St. Joseph - BayCare
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital Atlanta
    • Marietta, Georgia, United States, 30060
      • Wellstar Kennestone Hospital
  • Illinois
    • Evanston, Illinois, United States, 60201
      • North Shore U.
    • Naperville, Illinois, United States, 60540
      • Edward Elmhurst Health
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana U. Health
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • KUMC
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55427
      • Abbott Northwestern
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • St. Dominic
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Nebraska Medical
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Buffalo, New York, United States, 14203
      • University of Buffalo
    • Stony Brook, New York, United States, 11794
      • Stonybrook U.
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Regional
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • York, Pennsylvania, United States, 17403
      • Wellspan York
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Fort Sanders
    • Memphis, Tennessee, United States, 38104
      • Methodist U.
  • Texas
    • Houston, Texas, United States, 77030
      • UT Houston
    • Tyler, Texas, United States, 75702
      • Christus Trinity Medical Center
  • Virginia
    • Newport News, Virginia, United States, 23601
      • Riverside Regional Medical Center
  • Washington
    • Renton, Washington, United States, 98055
      • Valley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy	Device: Mechanical Thrombectomy (Penumbra System with Thunderbolt); Subject will receive Penumbra System with Thunderbolt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Immediate Post Procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Penumbra Inc.
• Investigators: Principal Investigator: Donald Frei, M.D., HCA HealthONE, LLC (Swedish Medical Center); Principal Investigator: David Fiorella, M.D., The Research Foundation for The State University of New York (Stony Brook University)

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): September 23, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Large Vessel Occlusion; Acute Ischemic Stroke; Penumbra System; AIS; Mechanical Thrombectomy; ADAPT; LVO; Thunderbolt Aspiration Tubing; A Direct Aspiration First Pass Technique
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia
• Other Study ID Numbers: 21340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No