Treatment With Endovascular Intervention for STroke Patients With Existing Disability

Stroke Clinical Trial

— TESTED  

Official title:

Treatment With Endovascular Intervention for STroke Patients With Existing Disability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911568
• Other study ID #: 2023-0299
• Status: Recruiting
• Start date: November 16, 2023
• Est. completion date: April 15, 2028

Study information

• Verified date: November 2023
• Source: University of Cincinnati
• Contact: Eva Mistry, MD
• Phone: 513-558-1291
• Email: mistryea[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1060
• Est. completion date: April 15, 2028
• Est. primary completion date: January 15, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Acute
• Stroke, Ischemic

Intervention

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.

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Hartford Health Hospital	Hartford	Connecticut
United States	University of California at Los Angeles	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	West Virginia University	Morgantown	West Virginia
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	HonorHealth	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Washington	Seattle	Washington

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	modified Rankin Scale (mRS)	Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)	At hospital discharge
Other	Montreal Cognitive Assessment (MoCA)	Montreal Cognitive Assessment (MoCA) (Note: MoCA range: 0-30, higher scores mean better outcome)	90 (±14) days after treatment initiation
Other	Barthel Index Scale	Barthel Index range: 0-100, higher scores mean participant is independent	90 (±14) days after treatment initiation
Other	Initial residence level or better time during first 90 days post-stroke	Number of days spend at the initial residence level or better during the first 90 days post-stroke	90 days after treatment initiation
Other	Zarit's Burden Interview (ZBI)	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). We will use the 4 item version of the ZBI which has good correlation with the full version.	90 (±14) days after treatment initiation
Other	Extended Thrombolysis in Cerebral Ischemia scale	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	At the end of EVT procedure
Other	Death		90 (±14) after treatment initiation
Other	Symptomatic intracranial hemorrhage	Evaluate modified Heidelberg definition	24 (±6) hours
Primary	modified Rankin Scale (mRS)	Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)	90 (±14) days after treatment initiation
Secondary	Disability-weighted (or utility-weighted) mRS	Standard utility weights applied to the mRS categories as follows: 1.0 for mRS level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6	90 (±14) days after treatment initiation
Secondary	Return to the pre-stroke mRS level	Returning to the pre-stroke mRS level post stroke	90 (±14) days after treatment initiation
Secondary	EQ-5D-5L	Quality of life assessment scale with range: 0 (worst health) to 100 (best health)	90 (±14) days after treatment initiation
Secondary	Academic Medical Center - Linear Disability Scale (ALDS)	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.	90 (±14) days after treatment initiation