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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05437055
• Other study ID #: 21340
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Penumbra Inc.
• Contact: Rahsaan Holley
• Phone: +1 703-969-3634
• Email: rholley[@]penumbrainc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Large Vessel Occlusion
• Stroke

Intervention

Device:
• Mechanical Thrombectomy (Penumbra System with Thunderbolt)
Subject will receive Penumbra System with Thunderbolt

Locations

Country	Name	City	State
United States	Piedmont Hospital Atlanta	Atlanta	Georgia
United States	Massachusetts General	Boston	Massachusetts
United States	University of Buffalo	Buffalo	New York
United States	MUSC	Charleston	South Carolina
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	HRI - Swedish	Englewood	Colorado
United States	North Shore U.	Evanston	Illinois
United States	UT Houston	Houston	Texas
United States	Indiana U. Health	Indianapolis	Indiana
United States	KUMC	Kansas City	Kansas
United States	Fort Sanders	Knoxville	Tennessee
United States	Wellstar Kennestone Hospital	Marietta	Georgia
United States	Methodist U.	Memphis	Tennessee
United States	Jackson Memorial (U. of Miami)	Miami	Florida
United States	Abbott Northwestern	Minneapolis	Minnesota
United States	Edward Elmhurst Health	Naperville	Illinois
United States	Yale New Haven	New Haven	Connecticut
United States	Christiana Care	Newark	Delaware
United States	Riverside Regional Medical Center	Newport News	Virginia
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Valley Medical Center	Renton	Washington
United States	Sharp Grossmont	San Diego	California
United States	Stonybrook U.	Stony Brook	New York
United States	St. Joseph - BayCare	Tampa	Florida
United States	Christus Trinity Medical Center	Tyler	Texas
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)	Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours	24hrs Post-Procedure
Secondary	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
Secondary	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
Secondary	Efficacy Endpoint: Time to Revascularization	Time to Revascularization	Index Procedure
Secondary	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
Secondary	Safety Endpoint: All-cause mortality	All-cause mortality at 90 days	90 Days Post-Procedure
Secondary	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 24hrs Post-Procedure