Clinical trials

The lab leads three investigator-initiated trials in acute stroke, funded by the National Institutes of Health, PCORI, and industry partners. Each asks a different question about how patients are triaged, imaged, and selected for endovascular treatment.

Card DONESYMPLE

DONE SYMPLE

Enrolling

Advanced imaging is how late-window patients are usually selected for thrombectomy. DONE SYMPLE tests whether an automated non-contrast CT tool can select patients instead, from 6 to 72 hours after stroke onset.


Funded by Medtronic
 

Card DIRECT

DIRECT

Enrolling

Patients with large vessel occlusion usually pass through emergency department imaging before reaching the angiography suite. DIRECT asks whether taking them straight there gets them to thrombectomy faster and improves patient health outcomes.


Funded by PCORI
 

Card Map Stroke

MAP-STROKE

Published

Guidelines route stroke patients by travel time. MAP-STROKE uses a Bayesian algorithm and geo-mapping to send each patient where they are most likely to recover, cutting thrombectomy delays by over 90 minutes, and by more than two hours in rural areas.

 

Funded by NIH/NINDS

Grants

Active grants

Addressing the paradox of poor outcomes despite successful recanalization in stroke

NIH/NINDS R01 NS138765 · 08/24 – 05/29 · Co-PI: Santiago Ortega-Gutierrez

Develop a longitudinal dataset of LVO-AIS patients with multiple imaging modalities, and create a machine learning tool to enable accurate prognostication of clinical outcomes and identify high-risk patients in whom recanalization is not sufficient.

Geospatial modeling for stroke care — MAP-STROKE

NIH/NINDS R01 NS127114 · 04/22 – 03/27 · Co-PI: Santiago Ortega-Gutierrez

Develop an algorithm of stroke triage that maximizes neurological recovery for stroke patients in the US and that can be integrated into a point-of-care decision support application for easy use by paramedics.

Safety and efficacy assessment of the Surpass Streamline flow diverter in the US

Stryker Neurovascular, grant 2020-HEM-006 · 09/20 – ongoing · PI: Santiago Ortega-Gutierrez

Evaluate the safety and efficacy of the Surpass Streamline flow diverter in a multicenter real-world cohort in the US.

C-arm cone beam CTP guided cerebrovascular interventions

NIH/NINDS 1U01EB021183-01 and Siemens · 09/17 – present · Institutional PI: Santiago Ortega-Gutierrez (PI: Beverly Aagaard-Kienitz)

Pilot trial to evaluate the predictability and accuracy of C-arm CTP of acute cerebral ischemia in the angiography suite.

Completed grants

Novel risk stratification score for patients with acute cerebral venous sinus thrombosis

NIH/NINDS R03 NS126804 · 12/22 – 12/24 · PI: Santiago Ortega-Gutierrez

Develop a stratification score to detect high-risk CVST patients at admission.

Novel risk stratification score to improve the care of patients with acute cerebral venous sinus thrombosis

CCoM clinical and educational grant, award 53380621 · 07/20 – 06/21 · PI: Santiago Ortega-Gutierrez

Develop a score for early stratification of CVST patients with poor prognosis using novel and objective clinical and imaging biomarkers that appear during early pathophysiological stages of CVST.

Machine learning to predict final infarct volume and functional outcomes

IIAI – CCoM pilot grant · 07/20 – 06/21 · PI: Santiago Ortega-Gutierrez

Determine the final infarct volume using patient-level clinical and imaging-based data for treatment times and success of recanalization in patients presenting with large vessel occlusion stroke and undergoing revascularization.

Deep immunoprofiling with high-parameter flow cytometry to identify immune correlates of long-term cognitive decline

ICTS – StrokeNet pilot · 07/19 – 06/21 · Co-PI: Santiago Ortega-Gutierrez

Identify clinically relevant immune correlates of long-term cognitive decline after stroke.

C-arm cone beam CTP guided cerebrovascular interventions — single center

Siemens neuroimaging pilot grant · 07/18 – 06/20 · PI: Santiago Ortega-Gutierrez

Single-center pilot study to evaluate the predictability and accuracy of C-arm CTP of acute cerebral ischemia in the angiography suite.

Research Areas

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Mechanical thrombectomy

Mechanical thrombectomy is a minimally invasive procedure performed in patients with acute ischemic stroke. A stent is advanced through the clot in the brain and then withdrawn to retrieve it, with or without aspiration.

Our goal: characterize mechanical thrombectomy as a treatment for ischemic stroke, including the factors associated with reperfusion status, imaging modalities, thrombolysis, event times, and functional outcomes.

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Cerebral venous sinus thrombosis

Cerebral venous sinus thrombosis is a rare form of stroke, most often seen in young adults and children. It occurs when a blood clot forms in the venous system of the brain, resulting in abnormal drainage or bleeding into brain tissue.

Our goal: investigate risk factors and novel biomarkers using machine learning methodologies, and develop a prognostic tool to identify high-risk individuals with CVST.

Aneursym Coiling

Aneurysm embolization

Cerebral aneurysms are enlargements of an artery that may be caused by weakening of the vessel wall. They can be treated with a minimally invasive procedure in which an embolization device occludes the enlargement.

Our goal: assess the technical, radiological, and clinical performance of aneurysm embolization devices, including stent-assisted coiling, the Surpass Streamline flow diverter, and the Woven EndoBridge.

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Arteriovenous malformation

Arteriovenous malformations are tangles of blood vessels that connect arteries directly to veins. They disrupt normal blood flow and oxygen circulation, and can rupture and bleed into the brain or spinal cord. Treatment typically uses catheter embolization or radiation therapy to close off the vessels.

Our goal: study AVM cases retrospectively to develop better ways to manage and treat these patients.

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Carotid stenting and angioplasty

In patients with internal carotid artery occlusion or stenosis, carotid stenting and angioplasty can be performed to recanalize the vessel and restore adequate blood flow to the brain.

Our goal: investigate and analyze the technical and clinical outcomes after endovascular treatment of carotid artery stenosis and occlusion.

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Cerebrovascular imaging

We study innovative imaging modalities using research software for computed tomography, magnetic resonance imaging, and CT perfusion, to devise novel approaches to the diagnosis, prognostication, and treatment of ischemic and hemorrhagic stroke. The core lab is equipped with image acquisition and optimization protocols for clinical and experimental studies.

Our goal: use algorithms and machine learning applications to evaluate biomarkers for functional and structural cerebrovascular disease.