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

Not Applicable

Completed

• Conditions: Ischemic Stroke

• 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.

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-15
• Study Start: 2019-07-16
• Primary Completion: 2023-02-25
• Study Completion: 2023-11-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (43)

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

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