Tests thrombectomy in large strokes with uncertain response
Tests clot removal in adults with large strokes from a blocked large artery.
Plain-language title generated from the registry record
Registry title: Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy
Key facts
- Where
- Palo Alto, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT06961487, who can take part
Where in United States
- Stanford UniversityPalo Alto, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Stanford University
- Trial code
- NCT06961487
- Record updated
- 8 May 2025
- Original description
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.Read full original descriptionShow less
Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy (OUTER LIMITS)
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.
Inclusion: Signs and symptoms consistent with an acute anterior circulation ischemic stroke and associated brain imaging; Baseline NIHSSS is ≥10 and remains ≥10 immediately prior to randomization; Treatment can be initiated within 24 hours of stroke onset or time last known well and within 120 minutes of completion of qualifying imaging; Functionally independent prior to stroke onset; Patient/ Legally Authorized Representative has signed the Informed Consent form.
Exclusion: Treated with tPA or TNK >4.5 hours after time last known well; Current participation in another investigational drug or device study; Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months; Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations; Known allergy to iodine that precludes an endovascular procedure; Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS; Severe, sustained hypertension (SBP >185 mmHg or DBP >110 mmHg); 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:; Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation; Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol); Baseline platelet count < 50,000/uL; Pregnant; Unable to undergo a contrast brain perfusion scan with either MRI or CT; Presumed septic embolus; suspicion of bacterial endocarditis; Significant mass effect with midline shift; Evidence of internal carotid artery dissection that is flow limiting or aortic dissection; Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device; 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).