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

Sponsor

Mercy Health Ohio (Other)

Overall Status

Recruiting

CT.gov ID

NCT03805308

Collaborator

(none)

300

Enrollment

Locations

Arms

39.6

Anticipated Duration (Months)

7.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Procedure: Intra-arterial Therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

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.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:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 16, 2019

Anticipated Primary Completion Date :

Jul 16, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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. = 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 (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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Health Center for Clinical Research	Little Rock	Arkansas	United States	72205
2	Sutter Institute for Medical Research	Sacramento	California	United States	95816
3	Sutter Valley Hospitals	Sacramento	California	United States	95816
4	California Pacific Medical Center & Mills Peninsula Medical Center	San Francisco	California	United States	94107
5	Los Robles Hospital and Medical Center	Thousand Oaks	California	United States	91360
6	Providence Saint John's Health Center	Torrance	California	United States	90503
7	Boca Raton Regional Hospital Inc.	Boca Raton	Florida	United States	33486
8	University of Miami	Coral Gables	Florida	United States	33146
9	Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital)	Delray Beach	Florida	United States	33484
10	Memorial Healthcare System - South Broward Hospital	Hollywood	Florida	United States	33021
11	Orlando Health Inc.	Orlando	Florida	United States	32806
12	University of South Florida	Tampa	Florida	United States	33612
13	Wellstar Health System, Inc.	Marietta	Georgia	United States	30062
14	University of Illinois at Chicago	Chicago	Illinois	United States	60612-7227
15	The University of Chicago	Chicago	Illinois	United States	60637
16	Northwestern University	Evanston	Illinois	United States	60208
17	central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital	Winfield	Illinois	United States	60190
18	The University of Iowa	Iowa City	Iowa	United States	52242
19	Baptist Healthcare System Inc. d/b/a Baptist Health Lexington	Lexington	Kentucky	United States	40503
20	LSU Health Sciences Center at Shreveport	Shreveport	Louisiana	United States	71103
21	University of Massachusetts	Worcester	Massachusetts	United States	01655
22	McLaren Health Care Corporation	Grand Blanc	Michigan	United States	48439
23	Sparrow Clinical Research Institute	Lansing	Michigan	United States	48912
24	SSM Health DePaul Hospital	Bridgeton	Missouri	United States	63044
25	Saint Louis University	Saint Louis	Missouri	United States	63103
26	The Community Hospital Group Inc. t/a JFK Medical Center	Edison	New Jersey	United States	08820
27	Univresity of Buffalo	Buffalo	New York	United States	14203
28	Feinstein Institute for Medical Research, Northwell	Manhasset	New York	United States	11030
29	Mercy Health St. Vincent Medical Center	Toledo	Ohio	United States	43608
30	Oregon Health and Science University	Portland	Oregon	United States	97214
31	Medical University of South Carolina	Charleston	South Carolina	United States	29425
32	DHR Health Institute for Research and Development	Edinburg	Texas	United States	78539
33	Texas Tech University of Health Sciences	El Paso	Texas	United States	79424
34	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
35	Texas Stroke Institute	Plano	Texas	United States	75075
36	Virginia Commonwealth University	Richmond	Virginia	United States	23219
37	Valley Medical Center	Renton	Washington	United States	98055
38	West Virginia University	Morgantown	West Virginia	United States	26506
39	Aurora Research Institute	Milwaukee	Wisconsin	United States	53233

Sponsors and Collaborators

Mercy Health Ohio

Investigators

Principal Investigator: Albert J Yoo, MD, PhD, Texas Stroke Institute
Principal Investigator: Osama O Zaidat, MD, MS, Mercy Health St. Vincent Medical Center