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

Completed · Not applicable

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT03805308

Run by

Mercy Health Ohio

People needed

300

Starts

2019-07-16

Expected to finish

2023-11-18

Last updated by the study team

2024-04-23

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Sutter Institute for Medical Research — Sacramento, California, United States
• California Pacific Medical Center & Mills Peninsula Medical Center — San Francisco, California, United States
• Los Robles Hospital and Medical Center — Thousand Oaks, California, United States
• Providence Saint John's Health Center — Torrance, California, United States
• Boca Raton Regional Hospital Inc. — Boca Raton, Florida, United States
• University of Miami — Coral Gables, Florida, United States
• Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital) — Delray Beach, Florida, United States
• Orlando Health Inc. — Orlando, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Wellstar Health System, Inc. — Marietta, Georgia, United States
• The University of Chicago — Chicago, Illinois, United States
• Northwestern University — Evanston, Illinois, United States
• AMITA Resurrection Medical Center and AMITA Saint Joseph Medical Center — Lisle, Illinois, United States
• Central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital — Winfield, Illinois, United States
• Lutheran Medical Group — Fort Wayne, Indiana, United States
• Munster Medical Research Foundation — Munster, Indiana, United States
• The University of Iowa — Iowa City, Iowa, United States
• Baptist Healthcare System Inc. d/b/a Baptist Health Lexington — Lexington, Kentucky, United States
• LSU Health Sciences Center at Shreveport — Shreveport, Louisiana, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• McLaren Health Care Corporation — Grand Blanc, Michigan, United States
• Western Michigan University Homer Stryker MD School of Medicine and Bronson Methodist Hospital — Kalamazoo, Michigan, United States

Full record on ClinicalTrials.gov

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