Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy

Not Applicable

• Conditions: Stroke, Acute; Ischemic Stroke, Acute

• Registration Number: NCT06961487
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is to assess the safety and efficacy of endovascular thrombectomy in both an early and extended time window in patients with large strokes due to large artery occlusion.

Detailed Description

This is a pilot prospective randomized trial of patients with acute ischemic anterior circulation strokes due to large artery occlusion who present with an eligible large ischemic core lesion, and who can be treated within 24 hours of stroke onset. The results of this pilot study will be used as preliminary data for a larger NIH-funded multi-center randomized trial to address the knowledge gaps in the management of this patient population.

Eligible patients will be randomized 1:1 to either:

Endovascular therapy plus medical therapy (based on current AHA guidelines)

or

Medical therapy (based on current AHA guidelines)

Endovascular Therapy: Patients randomized to endovascular therapy will be treated with aspiration thrombectomy devices and suction thrombectomy systems approved by the FDA for use in this study. Standard medical therapy, based on current AHA guidelines, will also be provided.

Medical Therapy: Patients randomized to medical therapy will receive standard medical therapy based on current AHA guidelines.

The researchers hope to learn if endovascular therapy plus standard medical therapy in this patient population leads to less disability after stroke than standard medical therapy alone.

Study Timeline

• Study Start: 2024-07-26
• Status Verified: 2025-03
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Primary Completion: 2028-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Signs and symptoms consistent with an acute anterior circulation ischemic stroke and associated brain imaging
2. Baseline NIHSSS is ≥10 and remains ≥10 immediately prior to randomization
3. Treatment can be initiated within 24 hours of stroke onset or time last known well and within 120 minutes of completion of qualifying imaging
4. Functionally independent prior to stroke onset
5. Patient/ Legally Authorized Representative has signed the Informed Consent form.

Exclusion Criteria

1. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months.
2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
3. Pregnant
4. Unable to undergo a contrast brain perfusion scan with either MRI or CT
5. Known allergy to iodine that precludes an endovascular procedure
6. Treated with tPA or TNK >4.5 hours after time last known well
7. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
8. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol)
9. Baseline platelet count < 50,000/uL
10. Severe, sustained hypertension (SBP >185 mmHg or DBP >110 mmHg)
11. Current participation in another investigational drug or device study
12. Presumed septic embolus; suspicion of bacterial endocarditis
13. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.

NEUROIMAGING Exclusion:

1. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
2. Significant mass effect with midline shift
3. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
4. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
5. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disability as measured on the modified Rankin Score	90 day	The modified Rankin Scale is a 7 point scale that measures degree of disability after a stroke. The scale range is as follows: 0: No symptoms at all; 1. No significant disability despite symptoms; able to carry out all usual duties and activities; 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3. Moderate disability; requiring some help, but able to walk without assistance; 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6. Dead

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with modified Rankin Scale 0-3	90 day	The modified Rankin Scale is a 7 point scale that measures degree of disability after a stroke. The scale range is as follows: 0: No symptoms at all; 1. No significant disability despite symptoms; able to carry out all usual duties and activities; 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3. Moderate disability; requiring some help, but able to walk without assistance; 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6. Dead
Percentage of patients requiring hemicraniectomy	from admission to discharge; up to 14 days	A surgical procedure that involves removing a large bone flap to relieve pressure on the brain due to swelling

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States