Clinical trial NCT05437055: THUNDER: Acute Ischemic Stroke Study with the Penumbra System® Including Thunderbolt™ Aspiration Tubing
Official title: THUNDER: Acute Ischemic Stroke Study with the Penumbra System® Including Thunderbolt™ Aspiration Tubing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy Endpoint: Angiographic Revascularization
timeFrame: Immediate Post Procedure
Secondary outcomes:
measure: Efficacy Endpoint: Angiographic Revascularization After First Pass
timeFrame: Index Procedure
measure: Efficacy Endpoint: Angiographic Revascularization
timeFrame: Immediate Post Procedure
measure: Efficacy Endpoint: Time to Revascularization
timeFrame: Index Procedure
measure: Efficacy Endpoint: Modified Rankin Scale (mRS)
timeFrame: 90 Days Post-Procedure
measure: Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)
timeFrame: 24 hours Post-Procedure
measure: Safety Endpoint: All-cause mortality
timeFrame: 90 Days Post-Procedure
measure: Safety Endpoint: Serious Adverse Events (SAEs)
timeFrame: Up to 24 hours Post-Procedure
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Abrazo West Campus
state: Arizona
city: San Diego
country: United States
facility: Sharp Grossmont
state: California
city: Englewood
country: United States
facility: HRI - Swedish
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven
state: Connecticut
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Miami
country: United States
facility: Jackson Memorial (U. of Miami)
state: Florida
city: Tampa
country: United States
facility: St. Joseph - BayCare
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital Atlanta
state: Georgia
city: Marietta
country: United States
facility: Wellstar Kennestone Hospital
state: Georgia
city: Evanston
country: United States
facility: North Shore U.
state: Illinois
city: Naperville
country: United States
facility: Edward Elmhurst Health
state: Illinois
city: Indianapolis
country: United States
facility: Indiana U. Health
state: Indiana
city: Kansas City
country: United States
facility: KUMC
state: Kansas
city: Boston
country: United States
facility: Massachusetts General
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott Northwestern
state: Minnesota
city: Jackson
country: United States
facility: St. Dominic
state: Mississippi
city: Omaha
country: United States
facility: Nebraska Medical
state: Nebraska
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Stony Brook
country: United States
facility: Stonybrook U.
state: New York
city: Wilmington
country: United States
facility: New Hanover Regional
state: North Carolina
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: York
country: United States
facility: Wellspan York
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Knoxville
country: United States
facility: Fort Sanders
state: Tennessee
city: Memphis
country: United States
facility: Methodist U.
state: Tennessee
city: Houston
country: United States
facility: UT Houston
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Medical Center
state: Texas
city: Newport News
country: United States
facility: Riverside Regional Medical Center
state: Virginia
city: Renton
country: United States
facility: Valley Medical Center
state: Washington
Study officials:
affiliation: HCA HealthONE, LLC (Swedish Medical Center)
name: Donald Frei, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Research Foundation for The State University of New York (Stony Brook University)
name: David Fiorella, M.D.
role: PRINCIPAL_INVESTIGATOR
References: