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ENROLLING BY INVITATION

NCT06961487

Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

Official title: Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy (OUTER LIMITS)

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-07-26

Completion Date

2028-05

Last Updated

2025-05-08

Healthy Volunteers

Conditions

Stroke, Acute Ischemic Stroke, Acute

Interventions

PROCEDURE

EndovascularThrombectomy

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.

DEVICE

Endovascular thrombectomy with any FDA-approved device

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

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).

Locations (1)

Stanford University

Palo Alto, California, United States