The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke

Status: Completed
Location: See all (43) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary objective of the trial is to establish the effectiveness of IAT (versus medical management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with adaptive enrichment to better define the upper limit of infarct volume for treatment eligibility. Furthermore, the investigators aim to determine whether certain subgroups of patients with large baseline infarcts will have a greater treatment benefit. Finally, the investigators will assess the agreement of ASPECTS scores between site investigators, the core imaging lab, and automated software.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 18 to 85 years of age

• Presenting with symptoms consistent with an acute ischemic stroke

• Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment

• NIHSS score \>6 at the time of randomization

• Ability to randomize within 24 hours of stroke onset

• Pre-stroke mRS score 0-1

• Ability to obtain signed informed consent

⁃ Imaging evidence of moderate-large infarct defined as:

• NCCT ASPECTS 2-5

Locations
United States
Arkansas
Baptist Health Center for Clinical Research
Little Rock
California
PIH Health Good Samaritan Hospital and PIH Health Whittier Hospital
Los Angeles
Pomona Valley Hospital Medical Center
Pomona
Sutter Institute for Medical Research
Sacramento
California Pacific Medical Center & Mills Peninsula Medical Center
San Francisco
Los Robles Hospital and Medical Center
Thousand Oaks
Providence Saint John's Health Center
Torrance
Florida
Boca Raton Regional Hospital Inc.
Boca Raton
University of Miami
Coral Gables
Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital)
Delray Beach
Orlando Health Inc.
Orlando
University of South Florida
Tampa
Georgia
Wellstar Health System, Inc.
Marietta
Iowa
The University of Iowa
Iowa City
Illinois
The University of Chicago
Chicago
Northwestern University
Evanston
AMITA Resurrection Medical Center and AMITA Saint Joseph Medical Center
Lisle
Central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital
Winfield
Indiana
Lutheran Medical Group
Fort Wayne
Munster Medical Research Foundation
Munster
Kentucky
Baptist Healthcare System Inc. d/b/a Baptist Health Lexington
Lexington
Louisiana
LSU Health Sciences Center at Shreveport
Shreveport
Massachusetts
University of Massachusetts
Worcester
Michigan
McLaren Health Care Corporation
Grand Blanc
Western Michigan University Homer Stryker MD School of Medicine and Bronson Methodist Hospital
Kalamazoo
Sparrow Clinical Research Institute
Lansing
Missouri
SSM Health DePaul Hospital
Bridgeton
Saint Louis University
Saint Louis
New Jersey
The Community Hospital Group Inc. t/a JFK Medical Center
Edison
Rutgers The State University
Piscataway
New York
University of Buffalo
Buffalo
Feinstein Institute for Medical Research, Northwell
Manhasset
Ohio
Mercy Health St. Vincent Medical Center
Toledo
ProMedica Toledo Hospital
Toledo
South Carolina
Medical University of South Carolina
Charleston
Texas
Texas Tech University of Health Sciences
El Paso
The University of Texas Health Science Center at Houston
Houston
Texas Stroke Institute
Plano
Utah
University of Utah
Salt Lake City
Virginia
Virginia Commonwealth University
Richmond
Washington
Valley Medical Center
Renton
Wisconsin
Aurora Research Institute
Milwaukee
West Virginia
West Virginia University
Morgantown
Time Frame
Start Date: 2019-07-16
Completion Date: 2023-11-18
Participants
Target number of participants: 300
Treatments
No_intervention: Medical Management
Patients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines.
Experimental: Intra-arterial Therapy
For patients randomized to the intra-arterial therapy arm, sites will use local protocols for femoral access, sedation, heparin infusion, monitoring, etc. Mechanical thrombectomy will be performed with FDA-approved thrombectomy devices in accordance with the IFU.
Related Therapeutic Areas
Sponsors
Leads: Mercy Health Ohio

This content was sourced from clinicaltrials.gov