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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2022
  • participants needed
    300
  • sponsor
    Mercy Health Ohio
Updated on 9 September 2021
stroke
infarct
thrombectomy

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.

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.

Details
Condition Ischemic Stroke
Treatment Intra-arterial Therapy
Clinical Study IdentifierNCT03805308
SponsorMercy Health Ohio
Last Modified on9 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 (l)
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
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