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

Status: Completed
Location: See all (32) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Abrazo West Campus
Goodyear
California
Sharp Grossmont
San Diego
Colorado
HRI - Swedish
Englewood
Connecticut
Yale New Haven
New Haven
Delaware
Christiana Care
Newark
Florida
Jackson Memorial (U. of Miami)
Miami
St. Joseph - BayCare
Tampa
Georgia
Piedmont Hospital Atlanta
Atlanta
Wellstar Kennestone Hospital
Marietta
Illinois
North Shore U.
Evanston
Edward Elmhurst Health
Naperville
Indiana
Indiana U. Health
Indianapolis
Kansas
KUMC
Kansas City
Massachusetts
Massachusetts General
Boston
UMass Memorial Medical Center
Worcester
Minnesota
Abbott Northwestern
Minneapolis
Mississippi
St. Dominic
Jackson
North Carolina
New Hanover Regional
Wilmington
Nebraska
Nebraska Medical
Omaha
New York
Albany Medical Center
Albany
University of Buffalo
Buffalo
Stonybrook U.
Stony Brook
Pennsylvania
Geisinger Medical Center
Danville
Thomas Jefferson University
Philadelphia
Wellspan York
York
South Carolina
MUSC
Charleston
Tennessee
Fort Sanders
Knoxville
Methodist U.
Memphis
Texas
UT Houston
Houston
Christus Trinity Medical Center
Tyler
Virginia
Riverside Regional Medical Center
Newport News
Washington
Valley Medical Center
Renton
Time Frame
Start Date: 2022-08-11
Completion Date: 2024-12-10
Participants
Target number of participants: 216
Treatments
Experimental: Single Arm
Use of Penumbra System including Thunderbolt in patients with acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy
Related Therapeutic Areas
Sponsors
Leads: Penumbra Inc.

This content was sourced from clinicaltrials.gov