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

Primary Purpose

Ischemic Stroke

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intra-arterial Therapy
Sponsored by
Mercy Health Ohio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Stroke, Ischemic Stroke, Thrombectomy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Health Center for Clinical Research
  • PIH Health Good Samaritan Hospital and PIH Health Whittier Hospital
  • Pomona Valley Hospital Medical Center
  • Sutter Institute for Medical Research
  • California Pacific Medical Center & Mills Peninsula Medical Center
  • Los Robles Hospital and Medical Center
  • Providence Saint John's Health Center
  • Boca Raton Regional Hospital Inc.
  • University of Miami
  • Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital)
  • Orlando Health Inc.
  • University of South Florida
  • Wellstar Health System, Inc.
  • The University of Chicago
  • Northwestern University
  • AMITA Resurrection Medical Center and AMITA Saint Joseph Medical Center
  • Central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital
  • Lutheran Medical Group
  • Munster Medical Research Foundation
  • The University of Iowa
  • Baptist Healthcare System Inc. d/b/a Baptist Health Lexington
  • LSU Health Sciences Center at Shreveport
  • University of Massachusetts
  • McLaren Health Care Corporation
  • Western Michigan University Homer Stryker MD School of Medicine and Bronson Methodist Hospital
  • Sparrow Clinical Research Institute
  • SSM Health DePaul Hospital
  • Saint Louis University
  • The Community Hospital Group Inc. t/a JFK Medical Center
  • Rutgers The State University
  • University of Buffalo
  • Feinstein Institute for Medical Research, Northwell
  • ProMedica Toledo Hospital
  • Mercy Health St. Vincent Medical Center
  • Medical University of South Carolina
  • Texas Tech University of Health Sciences
  • The University of Texas Health Science Center at Houston
  • Texas Stroke Institute
  • University of Utah
  • Virginia Commonwealth University
  • Valley Medical Center
  • West Virginia University
  • Aurora Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Medical Management

Intra-arterial Therapy

Arm Description

Patients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 3, 2018
Last Updated
December 13, 2022
Sponsor
Mercy Health Ohio
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1. Study Identification

Unique Protocol Identification Number
NCT03805308
Brief Title
The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke
Acronym
TESLA
Official Title
The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
February 16, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Health Ohio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Stroke, Ischemic Stroke, Thrombectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical Management
Arm Type
No Intervention
Arm Description
Patients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines.
Arm Title
Intra-arterial Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intra-arterial Therapy
Other Intervention Name(s)
Thrombectomy
Intervention Description
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.
Primary Outcome Measure Information:
Title
Utility-weighted 90-day Modified Rankin Score
Description
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
Time Frame
90 days post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 1. 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 (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert J Yoo, MD, PhD
Organizational Affiliation
Texas Stroke Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Osama O Zaidat, MD, MS
Organizational Affiliation
Mercy Health St. Vincent Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
PIH Health Good Samaritan Hospital and PIH Health Whittier Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Pomona Valley Hospital Medical Center
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Sutter Institute for Medical Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
California Pacific Medical Center & Mills Peninsula Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
Los Robles Hospital and Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Providence Saint John's Health Center
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Boca Raton Regional Hospital Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital)
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Orlando Health Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Wellstar Health System, Inc.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
AMITA Resurrection Medical Center and AMITA Saint Joseph Medical Center
City
Lisle
State/Province
Illinois
ZIP/Postal Code
60532
Country
United States
Facility Name
Central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Lutheran Medical Group
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Munster Medical Research Foundation
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Baptist Healthcare System Inc. d/b/a Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
LSU Health Sciences Center at Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
McLaren Health Care Corporation
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Western Michigan University Homer Stryker MD School of Medicine and Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
SSM Health DePaul Hospital
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63103
Country
United States
Facility Name
The Community Hospital Group Inc. t/a JFK Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
Rutgers The State University
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Feinstein Institute for Medical Research, Northwell
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
ProMedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Mercy Health St. Vincent Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Tech University of Health Sciences
City
El Paso
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Stroke Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Valley Medical Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Aurora Research Institute
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All shared data will be aggregate.
Citations:
PubMed Identifier
34125952
Citation
Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD007574. doi: 10.1002/14651858.CD007574.pub3.
Results Reference
derived

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

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