Clinical trial NCT03805308: The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke
Official title: The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: Stroke
Ischemic Stroke
Thrombectomy
Lead sponsor: Mercy Health Ohio
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: TESLA is a pragmatic, phase III, prospective, randomized, open-label, blinded endpoint, multicenter trial. Patients with moderate-large infarcts will be assigned to either best medical management alone (including intravenous recombinant tissue-type plasminogen activator (IV rtPA)) or intra-arterial treatment (IAT) with mechanical thrombectomy added to best medical management. Mechanical thrombectomy will be performed with FDA-approved thrombectomy devices in accordance with the instructions for use (IFU). Patients will be enrolled at up to 25 centers over an anticipated three-year period, with an additional year for trial closeout.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 18 to 85 years of age
2. Presenting with symptoms consistent with an acute ischemic stroke
3. Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment
4. NIHSS score \>6 at the time of randomization
5. Ability to randomize within 24 hours of stroke onset
6. Pre-stroke mRS score 0-1
7. Ability to obtain signed informed consent

Imaging evidence of moderate-large infarct defined as:

1. NCCT ASPECTS 2-5

Exclusion Criteria:

1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications
3. Refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
4. CT evidence of the following conditions:

   * Midline shift or herniation
   * Evidence of intracranial hemorrhage
   * Mass effect with effacement of the ventricles
5. Computed Tomography Angiography (CTA) evidence suggestive of difficult endovascular access per the treating interventionalist
6. Presence of cervical ICA occlusion (e.g., related to atherosclerotic disease or dissection)
7. Rapidly improving neurological status prior to randomization to NIHSS \<6
8. Bilateral strokes or multiple intracranial occlusions
9. Intracranial tumors
10. 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
11. Baseline platelet count \<30,000 per microliter (µl)
12. Life expectancy less than 90 days prior to stroke onset
13. Participation in another randomized clinical trial that could confound the evaluation of the study
14. 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

Primary outcomes:
measure: Utility-weighted 90-day Modified Rankin Score
timeFrame: 90 days post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Los Angeles
country: United States
facility: PIH Health Good Samaritan Hospital and PIH Health Whittier Hospital
state: California
city: Pomona
country: United States
facility: Pomona Valley Hospital Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center & Mills Peninsula Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hospital and Medical Center
state: California
city: Torrance
country: United States
facility: Providence Saint John's Health Center
state: California
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital Inc.
state: Florida
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Delray Beach
country: United States
facility: Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital)
state: Florida
city: Orlando
country: United States
facility: Orlando Health Inc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Marietta
country: United States
facility: Wellstar Health System, Inc.
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Lisle
country: United States
facility: AMITA Resurrection Medical Center and AMITA Saint Joseph Medical Center
state: Illinois
city: Winfield
country: United States
facility: Central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Lutheran Medical Group
state: Indiana
city: Munster
country: United States
facility: Munster Medical Research Foundation
state: Indiana
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
city: Lexington
country: United States
facility: Baptist Healthcare System Inc. d/b/a Baptist Health Lexington
state: Kentucky
city: Shreveport
country: United States
facility: LSU Health Sciences Center at Shreveport
state: Louisiana
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Grand Blanc
country: United States
facility: McLaren Health Care Corporation
state: Michigan
city: Kalamazoo
country: United States
facility: Western Michigan University Homer Stryker MD School of Medicine and Bronson Methodist Hospital
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Bridgeton
country: United States
facility: SSM Health DePaul Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Edison
country: United States
facility: The Community Hospital Group Inc. t/a JFK Medical Center
state: New Jersey
city: Piscataway
country: United States
facility: Rutgers The State University
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research, Northwell
state: New York
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Toledo
country: United States
facility: Mercy Health St. Vincent Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: El Paso
country: United States
facility: Texas Tech University of Health Sciences
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Plano
country: United States
facility: Texas Stroke Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Renton
country: United States
facility: Valley Medical Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora Research Institute
state: Wisconsin
Study officials:
affiliation: Texas Stroke Institute
name: Albert J Yoo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Health St. Vincent Medical Center
name: Osama O Zaidat, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD007574. doi: 10.1002/14651858.CD007574.pub3.