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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Endovascular thrombectomy is a minimally invasive procedure that uses catheters and devices to remove blood clots, restoring blood flow to the brain. The procedure involves inserting a catheter (a long, thin tube) into an artery, usually in the groin, and guiding it through the blood vessels to the site of the blocked artery/blood clot in the brain. After the catheter reaches the affected area, a specialized device is guided through the catheter to capture and remove the clot.
The following FDA approved thrombectomy devices will be included: Stryker Neurovascular Products: * AXS Vecta 74 Aspiration System * AXS Vecta Aspiration System (AXS Vecta 71 Aspiration Catheter and AXS Vecta 74 Aspiration Catheter) * AXS Vecta Intermediate Catheters (AXS Vecta 71 Intermediate Catheter \& AXS Vecta 74 Intermediate Catheter) * Trevo XP ProVue Retriever, 3x20 and 4x20 * Trevo XP ProVue Retriever, 4x30 * Trevo XP ProVue Retriever, 6x25 Medtronic Products: Solitaire X Revascularization Devices: * Solitaire X 4x20, 4x40, 6x40 * Solitaire X 3x20, 3x40 Aspiration catheters: * React 68 * React 71 * REACT-71-115 \& REACT-71-125 MicroVention Inc. Products: * SOFIA, Aspiration pump and tubing kit * SOFIA Plus Aspiration catheter * BOBBY balloon guide catheter * ERIC retrieval device
Stanford University
Palo Alto, California, United States
Disability as measured on the modified Rankin Score
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
Time frame: 90 day
Percentage of patients with modified Rankin Scale 0-3
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
Time frame: 90 day
Percentage of patients requiring hemicraniectomy
A surgical procedure that involves removing a large bone flap to relieve pressure on the brain due to swelling
Time frame: from admission to discharge; up to 14 days
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