Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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:
  5. Midline shift or herniation
  6. Evidence of intracranial hemorrhage
  7. Mass effect with effacement of the ventricles
  8. Computed Tomography Angiography (CTA) evidence suggestive of difficult endovascular access per the treating interventionalist
  9. Presence of cervical ICA occlusion (e.g., related to atherosclerotic disease or dissection)
  10. Rapidly improving neurological status prior to randomization to NIHSS <6
  11. Bilateral strokes or multiple intracranial occlusions
  12. Intracranial tumors
  13. 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
  14. Baseline platelet count <30,000 per microliter (µl)
  15. Life expectancy less than 90 days prior to stroke onset
  16. Participation in another randomized clinical trial that could confound the evaluation of the study
  17. 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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Masking
Single (Outcomes Assessor)
Masking Description
The patient and the treating physician will be aware of the treatment assignment. Assessment of outcome on NIHSS and mRS will be performed by a certified rater blinded to the treatment allocation. Each site must designate one or more individual(s) to perform these blinded assessments at 24 (16-36) hours, 6 ± 1 days or discharge (whichever is earlier), 30 days ± 7 days, and 90 days ± 30 days from randomization. Neuroimaging core lab evaluation will also be assessed in a blinded manner, except for angiographic revascularization grading which will only be performed for the intra-arterial treatment arm. Information on treatment allocation will be stored separately from the main study database. An unblinded independent statistician will combine treatment allocation data with the clinical data in order to report to the DSMB. A second blinded statistician will be part of the steering committee.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Procedure: Intra-arterial Therapy
    Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.
    Other names:
    • Thrombectomy

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Victor S Lopez
Victor.S.LopezRivera@uth.tmc.edu

More Details

NCT ID
NCT03805308
Status
Recruiting
Sponsor
Mercy Health Ohio

Study Contact

Mary S Patterson, MS
419-251-2335
mspatterson@mercy.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.