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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05437055
Other study ID # 21340
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 11, 2022
Est. completion date June 2025

Study information

Verified date June 2024
Source Penumbra Inc.
Contact Rahsaan Holley
Phone +1 703-969-3634
Email rholley@penumbrainc.com
Is FDA regulated No
Health authority
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

Study Design


Intervention

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

Locations

Country Name City State
United States Albany Medical Center Albany New York
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 Nebraska Medical Omaha Nebraska
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
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