TESTED: Treatment With Endovascular Intervention for STroke Patients With Existing Disability

• Sponsor: University of Cincinnati (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05911568
• Collaborator: Patient-Centered Outcomes Research Institute (Other), University of California, Los Angeles (Other), Icahn School of Medicine at Mount Sinai (Other)
• Enrollment: 1,060
• Locations: 12
• Anticipated Duration (Months): 53.5
• Patients Per Site: 88.3
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

TESTED will compare the risks and benefits of endovascular thrombectomy (EVT) to medical management (no EVT) in ischemic stroke patients who have a blockage in one of the large blood vessels in the brain and have a moderate-to-severe disability prior to their stroke.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Stroke, Acute; Stroke, Ischemic	Procedure: Endovascular Stroke Treatment; Other: Medical Management

Detailed Description

People with disabilities can suffer acute ischemic stroke (AIS). Endovascular clot removal is a breakthrough therapy for large vessel occlusion (LVO) AIS. Pre-stroke disabled patients were excluded from pivotal EVT stroke trials, so whether EVT is effective for those with pre-stroke disability is not known. As a result, two competing, widely-practiced, treatment paradigms have emerged based on individual practitioners' extrapolation of EVT benefits and safety from patients without a pre-stroke disability to those with disability: 1) Multimodal Medical Management (MMM; using intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol lowering medications, and other rehabilitative measures, as indicated) without EVT, and 2) EVT with the background of MMM.

TESTED will enroll patients with LVO-AIS who have a pre-existing disability, defined as pre-stroke modified Rankin score (mRS) 3 and 4, at 12 geographically distinct comprehensive stroke centers serving diverse race-ethnic and socioeconomic populations. The central objective of TESTED is to determine the comparative effectiveness and safety of these two different practice paradigms.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1060 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Treatment With Endovascular Intervention for STroke Patients With Existing Disability
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Jan 15, 2028
• Anticipated Study Completion Date: Apr 15, 2028

Arms and Interventions

Arm

Intervention/Treatment

Stroke patients with moderate-to-severe pre-stroke disability Patients with pre-stroke modified Rankin scale score 3 or 4, presenting with a anterior circulation large vessel occlusion stroke within 24 hours of last known well

Procedure: Endovascular Stroke Treatment; Patients who receive endovascular stroke treatment when they are admitted into the hospital, as determined by their clinical care team. Endovascular stroke treatment consist of catheter-based treatment for the blood clot causing the acute ischemic stroke; Other: Medical Management; Patients who receive MMM when they are admitted into the hospital, as determined by their clinical care team. MMM may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care. Specifically, this treatment does not involve endovascular stroke treatment.

Outcome Measures

Primary Outcome Measures

1. modified Rankin Scale (mRS) [90 (±14) days after treatment initiation]

   Score of 3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)

Secondary Outcome Measures

1. Disability-weighted (or utility-weighted) mRS [90 (±14) days after treatment initiation]

   Score of 3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)

2. Return to the pre-stroke mRS level [90 (±14) days after treatment initiation]

   Score of 3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)

3. EQ-5D-5L [90 (±14) days after treatment initiation]

   EQ-5D-5L (Scale range: 0 (worst health) to 100 (best health)

4. Academic Medical Center - Linear Disability Scale (ALDS) [90 (±14) days after treatment initiation]

   he Academic Medical Center Linear Disability Score (ALDS) is a recently developed generic item bank that measures the disability status of patients with a broad range of diseases, as expressed by the ability to perform activities in daily living.

Other Outcome Measures

1. modified Rankin Scale (mRS) [7 (±2) after treatment initiation]

   Score of 3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)

2. Montreal Cognitive Assessment (MoCA) [90 (±14) days after treatment initiation]

   Montreal Cognitive Assessment (MoCA) (Note: MoCA range: 0-30, higher scores mean better outcome)

3. Barthel Index Scale [90 (±14) days after treatment initiation]

   Barthel Index Scale (Note: Barthel Index range: 0-100, higher scores mean participant is independent)

4. Home-time during first 90 days post-stroke [90 days after treatment initiation]

   Score of 3, 4, 5 or 6 on the modified Rankin Scale (mRS)

5. Initial residence level or better time during first 90 days post-stroke [90 days after treatment initiation]

   Number of days spend at the initial residence level or better during the first 90 days post-stroke

6. Zarit's Burden Interview (ZBI) [90 (±14) days after treatment initiation]

   ZBI is a measure of caregiving burden that includes a 22 item interview. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always)

7. Extended Thrombolysis in Cerebral Ischemia scale [At the end of EVT procedure]

   The 7-point scale of eTICI is as follows: eTICI0 = 0% reperfusion; eTICI 1 = minimal flow past the occlusion but no perfusion ; eTICI2a = 1-49% reperfusion; eTICI2b50 = 50-66% reperfusion; eTICI2b67 = 67-89% reperfusion; eTICI2c = 90-99% reperfusion; eTICI3 = complete reperfusion

8. Death [90 (±14) after treatment initiation]

9. Symptomatic intracranial hemorrhage [24 (±6) hours]

   Evaluate modified Heidelberg definition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adult patients (≥18 years)

2. Moderate-to-severe pre-stroke functional disability, defined as mRS 3-4, for at least 3 months prior to stroke onset

3. Presenting to study hospital within 24 hours of last known well time

4. Diagnosis of acute ischemic stroke

5. Intracranial causative occlusion of the internal carotid artery or the M1 or dominant M2 segments of the middle cerebral artery visualized on the baseline CT(or MR) angiogram

6. Presenting CT Alberta Stroke Program Early CT (ASPECT) score ≥3 or MRI ASPECT score ≥4

7. Presenting NIH Stroke Scale score ≥6

8. Informed consent from patient if competent or from legally authorized representative

Exclusion Criteria:

1. Known diagnosis of a terminal cancer or terminal illness at the time of stroke

2. Assessment of pre-stroke functional status cannot be performed during the hospital stay

3. Pre-stroke disability deemed temporary in the investigator's opinion (for example, recovering from a general medical illness or traumatic bodily injury)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth	Phoenix	Arizona	United States	85013
2	University of California at Los Angeles	Los Angeles	California	United States	90095
3	Hartford Health Hospital	Hartford	Connecticut	United States	06106
4	Yale University	New Haven	Connecticut	United States	06510
5	University of Miami	Miami	Florida	United States	33125
6	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
7	Columbia University	New York	New York	United States	10032
8	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45219
9	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
10	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
11	University of Washington	Seattle	Washington	United States	98104
12	West Virginia University	Morgantown	West Virginia	United States	26506

Sponsors and Collaborators

• University of Cincinnati
• Patient-Centered Outcomes Research Institute
• University of California, Los Angeles
• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Eva Mistry, MD, University of Cincinnati
• Principal Investigator: Jeffrey Saver, MD, Ronald Reagan UCLA Medical Center
• Principal Investigator: J Mocco, MD, Icahn School of Medicine at Mount Sinai
• Principal Investigator: Heidi Sucharew, PhD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eva A. Mistry, Assistant Professor, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT05911568
• Other Study ID Numbers: 2023-0299
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke

Study Results

No Results Posted as of Jun 22, 2023