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

Ischemic Stroke Clinical Trial

— TESLA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805308
• Other study ID #: 2018-49
• Status: Completed
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: November 18, 2023

Study information

• Verified date: April 2024
• Source: Mercy Health Ohio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 18, 2023
• Est. primary completion date: February 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	Boca Raton Regional Hospital Inc.	Boca Raton	Florida
United States	SSM Health DePaul Hospital	Bridgeton	Missouri
United States	University of Buffalo	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	The University of Chicago	Chicago	Illinois
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	The Community Hospital Group Inc. t/a JFK Medical Center	Edison	New Jersey
United States	Texas Tech University of Health Sciences	El Paso	Texas
United States	Northwestern University	Evanston	Illinois
United States	Lutheran Medical Group	Fort Wayne	Indiana
United States	McLaren Health Care Corporation	Grand Blanc	Michigan
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	The University of Iowa	Iowa City	Iowa
United States	Western Michigan University Homer Stryker MD School of Medicine and Bronson Methodist Hospital	Kalamazoo	Michigan
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Baptist Healthcare System Inc. d/b/a Baptist Health Lexington	Lexington	Kentucky
United States	AMITA Resurrection Medical Center and AMITA Saint Joseph Medical Center	Lisle	Illinois
United States	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	Feinstein Institute for Medical Research, Northwell	Manhasset	New York
United States	Wellstar Health System, Inc.	Marietta	Georgia
United States	Aurora Research Institute	Milwaukee	Wisconsin
United States	West Virginia University	Morgantown	West Virginia
United States	Munster Medical Research Foundation	Munster	Indiana
United States	Orlando Health Inc.	Orlando	Florida
United States	Rutgers The State University	Piscataway	New Jersey
United States	Texas Stroke Institute	Plano	Texas
United States	Pomona Valley Hospital Medical Center	Pomona	California
United States	Valley Medical Center	Renton	Washington
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Sutter Institute for Medical Research	Sacramento	California
United States	Saint Louis University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	California Pacific Medical Center & Mills Peninsula Medical Center	San Francisco	California
United States	LSU Health Sciences Center at Shreveport	Shreveport	Louisiana
United States	University of South Florida	Tampa	Florida
United States	Los Robles Hospital and Medical Center	Thousand Oaks	California
United States	Mercy Health St. Vincent Medical Center	Toledo	Ohio
United States	ProMedica Toledo Hospital	Toledo	Ohio
United States	Providence Saint John's Health Center	Torrance	California
United States	Central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital	Winfield	Illinois
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Health Ohio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utility-weighted 90-day Modified Rankin Score	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.; = No significant disability despite symptoms; able to carry out all usual duties and activities.; = Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance.; = Moderate disability requiring some help, but able to walk without assistance.; = Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.; = Severe disability; bedridden, incontinent, and requiring constant nursing care and attention.; = Death	90 days post randomization