Clinical trial NCT06961487: Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy
Official title: Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy (OUTER LIMITS)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke, Acute
Ischemic Stroke, Acute
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Disability as measured on the modified Rankin Score
timeFrame: 90 day
Secondary outcomes:
measure: Percentage of patients with modified Rankin Scale 0-3
timeFrame: 90 day
measure: Percentage of patients requiring hemicraniectomy
timeFrame: from admission to discharge; up to 14 days
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Gregory Albers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Jeremy Heit, MD
role: PRINCIPAL_INVESTIGATOR
References: