Status:
ENROLLING_BY_INVITATION
Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy
Lead Sponsor:
Stanford University
Conditions:
Stroke, Acute
Ischemic Stroke, Acute
Eligibility:
All Genders
18-90 years
Phase:
NA
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...
Eligibility Criteria
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
- 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
- Pregnant
- Unable to undergo a contrast brain perfusion scan with either MRI or CT
- Known allergy to iodine that precludes an endovascular procedure
- Treated with tPA or TNK \>4.5 hours after time last known well
- Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
- Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol)
- Baseline platelet count \< 50,000/uL
- Severe, sustained hypertension (SBP \>185 mmHg or DBP \>110 mmHg)
- Current participation in another investigational drug or device study
- Presumed septic embolus; suspicion of bacterial endocarditis
- 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
- 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).
Key Trial Info
Start Date :
July 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06961487
Start Date
July 26 2024
End Date
May 1 2028
Last Update
May 8 2025
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94304