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

NCT05437055 | Completed DMC FDA Device

• 1 other identifier: 21340
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 32

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.

Conditions

Acute Ischemic Stroke; Large Vessel Occlusion

Keywords

Acute Ischemic Stroke; AIS; Large Vessel Occlusion; LVO; Mechanical Thrombectomy; Penumbra System; Thunderbolt Aspiration Tubing; A Direct Aspiration First Pass Technique; ADAPT

Outcome Measures

Primary Outcomes (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

  Immediate Post Procedure

Secondary Outcomes (7)

• Efficacy Endpoint: Angiographic Revascularization After First Pass

  Index Procedure

• Efficacy Endpoint: Angiographic Revascularization

  Immediate Post Procedure

• Efficacy Endpoint: Time to Revascularization

  Index Procedure

• Efficacy Endpoint: Modified Rankin Scale (mRS)

  90 Days Post-Procedure

• Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)

  24 hours Post-Procedure

Study Arms (1)

Single Arm

EXPERIMENTAL

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)

Interventions

Mechanical Thrombectomy (Penumbra System with Thunderbolt) DEVICE

Subject will receive Penumbra System with Thunderbolt

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (32)

Abrazo West Campus

Goodyear, Arizona, 85395, United States

Location

Sharp Grossmont

San Diego, California, 92123, United States

Location

HRI - Swedish

Englewood, Colorado, 80113, United States

Location

Yale New Haven

New Haven, Connecticut, 06520, United States

Location

Christiana Care

Newark, Delaware, 19718, United States

Location

Jackson Memorial (U. of Miami)

Miami, Florida, 33136, United States

Location

St. Joseph - BayCare

Tampa, Florida, 33614, United States

Location

Piedmont Hospital Atlanta

Atlanta, Georgia, 30309, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

North Shore U.

Evanston, Illinois, 60201, United States

Location

Edward Elmhurst Health

Naperville, Illinois, 60540, United States

Location

Indiana U. Health

Indianapolis, Indiana, 46202, United States

Location

KUMC

Kansas City, Kansas, 66160, United States

Location

Massachusetts General

Boston, Massachusetts, 02114, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Abbott Northwestern

Minneapolis, Minnesota, 55427, United States

Location

St. Dominic

Jackson, Mississippi, 39216, United States

Location

Nebraska Medical

Omaha, Nebraska, 68198, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Stonybrook U.

Stony Brook, New York, 11794, United States

Location

New Hanover Regional

Wilmington, North Carolina, 28401, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Wellspan York

York, Pennsylvania, 17403, United States

Location

MUSC

Charleston, South Carolina, 29425, United States

Location

Fort Sanders

Knoxville, Tennessee, 37916, United States

Location

Methodist U.

Memphis, Tennessee, 38104, United States

Location

UT Houston

Houston, Texas, 77030, United States

Location

Christus Trinity Medical Center

Tyler, Texas, 75702, United States

Location

Riverside Regional Medical Center

Newport News, Virginia, 23601, United States

Location

Valley Medical Center

Renton, Washington, 98055, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: August 11, 2022
• Primary Completion: September 23, 2024
• Study Completion: December 10, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)