The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke
- Conditions
- Ischemic Stroke
- Interventions
- Procedure: Intra-arterial Therapy
- Registration Number
- NCT03805308
- Lead Sponsor
- Mercy Health Ohio
- Brief 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.
- Detailed Description
Prospective, randomized, open-label, blinded endpoint study. Patients presenting with symptoms of AIS who have evidence of a moderate-large infarct volume (Non-contrast CT Alberta Stroke Program Early CT score \[NCCT ASPECTS\] 2-5 in the anterior circulation will be assigned to either best medical management alone (including IV rtPA) or intra-arterial treatment (IAT) with mechanical thrombectomy added to best medical management. Each treated patient will be followed and assessed for 3 months after randomization.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
-
Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
-
Known severe allergy (more than a rash) to contrast media uncontrolled by medications
-
Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg)
-
CT evidence of the following conditions:
- Midline shift or herniation
- Evidence of intracranial hemorrhage
- Mass effect with effacement of the ventricles
-
Computed Tomography Angiography (CTA) evidence suggestive of difficult endovascular access per the treating interventionalist
-
Presence of cervical ICA occlusion (e.g., related to atherosclerotic disease or dissection)
-
Rapidly improving neurological status prior to randomization to NIHSS <6
-
Bilateral strokes or multiple intracranial occlusions
-
Intracranial tumors
-
Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >3.0 or Partial Thromboplastin Time (PTT) >3 times of normal
-
Baseline platelet count <30,000 per microliter (µl)
-
Life expectancy less than 90 days prior to stroke onset
-
Participation in another randomized clinical trial that could confound the evaluation of the study
-
Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intra-arterial Therapy 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.
- Primary Outcome Measures
Name Time Method Utility-weighted 90-day Modified Rankin Score 90 days post randomization Scale used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death.
0 = No symptoms at all.
1. = No significant disability despite symptoms; able to carry out all usual duties and activities.
2. = Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance.
3. = Moderate disability requiring some help, but able to walk without assistance.
4. = Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
5. = Severe disability; bedridden, incontinent, and requiring constant nursing care and attention.
6. = Death
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
Lutheran Medical Group
🇺🇸Fort Wayne, Indiana, United States
Western Michigan University Homer Stryker MD School of Medicine and Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Feinstein Institute for Medical Research, Northwell
🇺🇸Manhasset, New York, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
ProMedica Toledo Hospital
🇺🇸Toledo, Ohio, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
California Pacific Medical Center & Mills Peninsula Medical Center
🇺🇸San Francisco, California, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
PIH Health Good Samaritan Hospital and PIH Health Whittier Hospital
🇺🇸Los Angeles, California, United States
Pomona Valley Hospital Medical Center
🇺🇸Pomona, California, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Providence Saint John's Health Center
🇺🇸Torrance, California, United States
Los Robles Hospital and Medical Center
🇺🇸Thousand Oaks, California, United States
Central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
LSU Health Sciences Center at Shreveport
🇺🇸Shreveport, Louisiana, United States
AMITA Resurrection Medical Center and AMITA Saint Joseph Medical Center
🇺🇸Lisle, Illinois, United States
Munster Medical Research Foundation
🇺🇸Munster, Indiana, United States
The University of Iowa
🇺🇸Iowa City, Iowa, United States
SSM Health DePaul Hospital
🇺🇸Bridgeton, Missouri, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Rutgers The State University
🇺🇸Piscataway, New Jersey, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Texas Stroke Institute
🇺🇸Plano, Texas, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Wellstar Health System, Inc.
🇺🇸Marietta, Georgia, United States
Boca Raton Regional Hospital Inc.
🇺🇸Boca Raton, Florida, United States
University of Miami
🇺🇸Coral Gables, Florida, United States
McLaren Health Care Corporation
🇺🇸Grand Blanc, Michigan, United States
Valley Medical Center
🇺🇸Renton, Washington, United States
The Community Hospital Group Inc. t/a JFK Medical Center
🇺🇸Edison, New Jersey, United States
Texas Tech University of Health Sciences
🇺🇸El Paso, Texas, United States
Mercy Health St. Vincent Medical Center
🇺🇸Toledo, Ohio, United States
Orlando Health Inc.
🇺🇸Orlando, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Sutter Institute for Medical Research
🇺🇸Sacramento, California, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Aurora Research Institute
🇺🇸Milwaukee, Wisconsin, United States
Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital)
🇺🇸Delray Beach, Florida, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Baptist Healthcare System Inc. d/b/a Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States