THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing
Primary Purpose
Acute Ischemic Stroke, Large Vessel Occlusion
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mechanical Thrombectomy (Penumbra System with Thunderbolt)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute Ischemic Stroke, AIS, Large Vessel Occlusion, LVO, Mechanical Thrombectomy, Penumbra System, Thunderbolt Aspiration Tubing, A Direct Aspiration First Pass Technique, ADAPT
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Sharp GrossmontRecruiting
- HRI - SwedishRecruiting
- Yale New HavenRecruiting
- Christiana CareRecruiting
- Jackson Memorial (U. of Miami)Recruiting
- St. Joseph - BayCareRecruiting
- Piedmont Hospital AtlantaRecruiting
- Indiana U. HealthRecruiting
- KUMCRecruiting
- Massachusetts GeneralRecruiting
- UMass Memorial Medical CenterRecruiting
- Abbott NorthwesternRecruiting
- University of BuffaloRecruiting
- Stonybrook U.Recruiting
- Geisinger Medical CenterRecruiting
- Thomas Jefferson UniversityRecruiting
- MUSCRecruiting
- Fort SandersRecruiting
- Methodist U.Recruiting
- UT HoustonRecruiting
- Christus Trinity Medical CenterRecruiting
- Riverside Regional Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy
Outcomes
Primary Outcome Measures
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
Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)
Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours
Secondary Outcome Measures
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
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
Efficacy Endpoint: Time to Revascularization
Time to Revascularization
Efficacy Endpoint: Modified Rankin Scale (mRS)
Functional outcomes measured by mRS 0-2 at 90 days
(0 no symptoms - 5 severe disability)
Safety Endpoint: All-cause mortality
All-cause mortality at 90 days
Safety Endpoint: Serious Adverse Events (SAEs)
Incidence of device related, and/or procedure related Serious Adverse Events (SAEs) within 24 hours post-procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05437055
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penumbra Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
275 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy
Intervention Type
Device
Intervention Name(s)
Mechanical Thrombectomy (Penumbra System with Thunderbolt)
Intervention Description
Subject will receive Penumbra System with Thunderbolt
Primary Outcome Measure Information:
Title
Efficacy Endpoint: Angiographic Revascularization
Description
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
Time Frame
Immediate Post Procedure
Title
Safety Endpoint: Rate of Symptomatic Intracranial Hemorrhage (sICH)
Description
Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours
Time Frame
24hrs Post-Procedure
Secondary Outcome Measure Information:
Title
Efficacy Endpoint: Angiographic Revascularization After First Pass
Description
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
Time Frame
Index Procedure
Title
Efficacy Endpoint: Angiographic Revascularization
Description
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
Time Frame
Immediate Post Procedure
Title
Efficacy Endpoint: Time to Revascularization
Description
Time to Revascularization
Time Frame
Index Procedure
Title
Efficacy Endpoint: Modified Rankin Scale (mRS)
Description
Functional outcomes measured by mRS 0-2 at 90 days
(0 no symptoms - 5 severe disability)
Time Frame
90 Days Post-Procedure
Title
Safety Endpoint: All-cause mortality
Description
All-cause mortality at 90 days
Time Frame
90 Days Post-Procedure
Title
Safety Endpoint: Serious Adverse Events (SAEs)
Description
Incidence of device related, and/or procedure related Serious Adverse Events (SAEs) within 24 hours post-procedure
Time Frame
Up to 24hrs Post-Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ravi Radhakrishnan
Phone
+1 404.519.7065
Email
rradhakrishnan@PENUMBRAINC.COM
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Lawson
Phone
+1 510.440.5699
Email
blawson@PENUMBRAINC.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Frei, M.D.
Organizational Affiliation
HCA HealthONE, LLC (Swedish Medical Center)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Fiorella, M.D.
Organizational Affiliation
The Research Foundation for The State University of New York (Stony Brook University)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Grossmont
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
HRI - Swedish
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Name
Christiana Care
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Individual Site Status
Recruiting
Facility Name
Jackson Memorial (U. of Miami)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Joseph - BayCare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Hospital Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana U. Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
KUMC
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Name
Abbott Northwestern
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Name
Stonybrook U.
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
MUSC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Fort Sanders
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Individual Site Status
Recruiting
Facility Name
Methodist U.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Christus Trinity Medical Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Recruiting
Facility Name
Riverside Regional Medical Center
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration Tubing
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