Justin Fraser, MD, FAANS, FAHA

As Director of Cerebrovascular Surgery at University of Kentucky, I currently practice both open and endovascular cerebrovascular neurosurgery, which includes providing all facets of interventional treatment for hemorrhagic and ischemic stroke. My research has included both benchwork and clinical efforts, and my current research focus is early detection and therapeutic approaches for ischemic stroke. My clinical background has included publications in the management of acute ischemic stroke, subarachnoid hemorrhage, and interventional management of cerebrovascular disease. I am the principal investigator and site-PI on several clinical studies, including several multicenter clinical trials evaluating aneurysm treatments, as well as multiple registries for treatment of ischemic stroke. I am currently PI for two investigator-initiated Phase I studies of intra-arterial administration of neuroprotective agents in acute stroke. I am also PI of a funded Phase I study to evaluate a point-of-care detection device that uses a drop of whole blood to determine the presence of stroke and traumatic brain injury through a serum biomarker. My most current endeavors focus on translating potential neuroprotective agents into clinical application within the context of current stroke therapy, and evaluating the micro-environment of the vascular elements in the brain during acute large vessel stroke in the human condition.

Fraser Laboratory:

UK Center for Advanced Translational Stroke Science

For questions and inquiries, please contact Jacque Frank at j.frank@uky.edu

Current Research:

MASTER (Moyamoya and Stroke Tissue Evaluation and Repository)

Status: Recruiting

Principal Investigator at UK: Jill Roberts, PhD Department of Neurosurgery, University of Kentucky

Sub Investigator at UK: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky    Jessica Lee, MD, Department of Neurology, University of Kentucky

Sponsor: NIH National Center for Advancing Translational Sciences and UK Center for Clinical and Translational Science

Purpose: This is an un-blinded clinical and biological registry to evaluate specific questions to aid in the understanding of moyamoya syndrome.  Blood samples and clinical data are evaluated for specific inflammatory proteins and their correltion to moyamoya severity and presence of comorbidities.

Condition: Moyamoya

Intervention: There is no therapeutic intervention involved in this study.

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator 

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

EMBOLISE (Embolization of the Middle Meningeal Artery with ONYXTM Liquid Embolic System in the Treatment of Subacute and Chronic Subdural Hematoma)

Status: Recruiting

Principal Investigator at UK: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Sub Investigator at UK: David Dornbos, III, MD, Department of Neurosurgery, University of Kentucky

Sponsor: Medtronic Neurovascular

Design: A multi-center, prospective, randomized, interventional, controlled, open label, adaptive design

Purpose: To evaluate the safety and effectiveness of Onyx™ LES embolization of the MMA as an adjunct to conventional treatment (surgery or observation) for symptomatic subacute or chronic subdural hematoma.

Condition: Subdural Hematoma

Study Cohorts: Surgery Cohort and Observation Cohort, with control and experimental arms within each cohort.

Other information: ClinicalTrials.gov Identifier: NCT04402632

https://clinicaltrials.gov/ct2/show/NCT04402632?term=embolise&draw=2&rank=1

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator 

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

ELEVATE (EvaLuate EndoVascular treatment of Acutely reputured shallow intradural aneurysms with the Pipeline™ Flex Embolization Device with Shield TEchnology™)

Status: Upcoming/not yet recruiting

Principal Investigator at UK: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Sub Investigator at UK: David Dornbos, III, MD, Department of Neurosurgery, University of Kentucky

Sponsor: Medtronic Neurovascular

Design: Multicenter, prospective, single-arm, adaptive IDE study

Purpose: To assess the safety and effectiveness of constructive treatment with the Pipeline, Shield Device in adults with acutely ruptured intradural aneurysms that are shallow (dome to neck ratio 1) and are deemed unfavorable for both, clipping and coiling.

Condition: Ruptured intradural aneurysms

Other information: ClinicalTrials.gov Identifier: NCT04391803

https://clinicaltrials.gov/ct2/show/NCT04391803?term=elevate&cond=aneurysm&draw=2&rank=1

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator 

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

CITADEL (The Citadel Embolization Study)

Status: Upcoming/not yet recruiting

Principal Investigator-Initiated Study / Principal Investigator: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Sub Investigator at UK: David Dornbos, III, MD, Department of Neurosurgery, University of Kentucky

Internal Financial Sponsor: Stryker Neurovascular 

Purpose: The purpose of this study is to gather preliminary safety and effectiveness data on Stryker Neurovascular’s Next Generation Target Detachable Coil (Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of wide-neck intracranial aneurysms. 

Condition: Intracranial aneurysms

Study Design: Prospective, multicenter, single-arm, non-randomized clinical study

Other information: ClinicalTrials.gov Identifier: NCT04057352

https://clinicaltrials.gov/ct2/show/NCT04057352?term=citadel&cond=aneurysm&draw=2&rank=1

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

MAVARIC (Magnesium and Verapamil After Recanalization in Ischemia of the Cerebrum in the Kentucky regional population: a clinical and translational study)

Status: This is a clinical study that is currently enrolling subjects

Principal Investigator-Initiated Study / Principal Investigator: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Internal Financial Sponsor: University of Kentucky College of Medicine (COM) and Center for Clinical and Translational Science (CCTS) Multidisciplinary Value Program (MVP) Grant Program

Purpose: This is a phase I, blinded-outcome, randomized, placebo controlled study to investigate the safety and feasibility of super-selective intra-arterial administration of verapamil and magnesium sulfate immediately following successful endovascular thrombectomy as a potential neuroprotective synergistic therapeutic strategy in emergent large vessel occlusion stroke. This trial represents the first time that magnesium sulfate will be evaluated in human subjects as a superselectively administered neuroprotective agent administered in an acute time frame as an adjunct to intra-arterial thrombectomy. Furthermore, it will represent the first trial to evaluate combinational therapy for acute stroke neuroprotection.

Condition: Acute Ischemic Stroke

Intervention: Magnesium and verapamil after recanalization in ischemia of the cerebrum

Allocation: Randomized

Masking: Single (Outcomes Assessor)

Other information: ClinicalTrials.gov ID # NCT02912663

https://clinicaltrials.gov/ct2/show/NCT02912663?term=02912663&rank=1

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator 

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

BACTRAC (Blood and Clot Thrombectomy Registry and Collaboration)

Status: This prospective open enrollment clinical registry is currently enrolling subjects.

Principal Investigator-Initiated Study / Principal Investigator: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Internal Financial Sponsor: University of Kentucky Department of Neurology

Design: The study is an open, unblinded, clinical and biologic registry and tissue bank to evaluate specific questions that are novel to understanding stroke in the human condition.

Purpose: The purpose of this prospective open enrollment registry and tissue bank is to evaluate arterial blood and thrombus removed during the standard thrombectomy procedure, which will then be used for the purposes of identifying biological markers, inflammatory cell infiltrates, and biological states in large vessel occlusive stroke in the human condition. The primary objectives are to evaluate the feasibility of obtaining distal clot blood during thrombectomy; develop a group of biosamples (blood and clots) to evaluate novel proteins, cell types, and cytokines in acute ischemic stroke in the human condition, and evaluate specific biomarkers, proteins, and leukocyte populations in stroke in the human condition.

This study represents the first time that thrombectomy technique will be utilized to collect focal blood samples and the clot related brain infarction to understand relationships between the local inflammatory cascade and clinical variables such as age, gender, time from symptoms to thrombectomy, and stroke imaging results. Characterizing these relationships is vital in the formulation of related therapeutics. Issues of gender-differences, age-based variations, and co-morbidities all engender heterogeneity, which plague translation of stroke research from animal to human. By starting with the human condition, the investigators aim to minimize this loss in translation. Overall, this study will have a great impact on our knowledge of stroke pathology. In essence, this could fundamentally change not only how the investigators develop treatment strategies for the stroke patient population but allow us to individualize the treatment dependent on time after stroke, age, sex, and co-morbidities. Molecular techniques that are impractical when delivered systemically could be delivered locally to impede the early inflammation.

Condition: Acute Ischemic Stroke

Participants: Participants must have an acute thromboembolus within an intracranial artery in the anterior circulation (internal carotid, anterior cerebral, middle cerebral), which undergoes mechanical thrombectomy per standard of care.  The study population will include up to 250 subjects.

Intervention: There is no therapeutic intervention involved in this study.

Other information: ClinicalTrials.gov ID # NCT03153683

https://register.clinicaltrials.gov/prs/app/template/EditRecord.vm?epmode=Edit&listmode=Edit&uid=U0000IBN&ts=9&sid=S0006L6Z&cx=-ciqde4

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator 

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

MIND (A Prospective, Multicenter Study of Artemi a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage)

Status: Recruiting

Principal Investigator at UK: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Sponsor: Penumbra, Inc.

Design:

• Allocation: Randomized

• Intervention Model: Parallel Assignment

• Intervention Model Description: Subjects will be randomized to either minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management (MIS group) or best medical management alone (2:1) (MM).

• Masking: Single (Outcomes Assessor)

• Masking Description: 180 day mRS is blinded

• Primary Purpose: Treatment

Purpose: The primary objective of this multicenter randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the treatment of intracerebral hemorrhage (ICH).

Condition: Intracerebral hemorrhage (ICH), Cerebral Hemorrhage, Brain Hemorrhage, Cerebral Parenchymal Hemorrhage.

Participants: The target population are patients ≥ 18 and ≤ 80 years of age who have a diagnosis of spontaneous, non-traumatic, intracerebral hemorrhage (ICH) ranging ≥ 20 and < 80 cc, with an associated significant neurological deficit (NIHSS ≥ 6) who do not require emergent open surgical decompression related to uncontrolled intracranial pressure or mass effect.

Intervention:

• Device: Artemis + Medical Management

Subject will receive best MM in addition to the MIS procedure with Artemis.

• Other: Best Medical Management Alone (MM)

Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.

Study Arms:

• Experimental: Artemis + Medical Management (MIS):

  • Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
    
    Intervention: Device: Artemis + Medical Management

• Active Comparator: Best Medical Management Alone (MM)

  • Best medical management alone per standard of care at treating institution
    
    Intervention: Other: Best Medical Management Alone (MM)

Other information: ClinicalTrials.gov ID # NCT03342664

https://clinicaltrials.gov/ct2/show/record/NCT03342664?term=MIND+Intracerebral+Hemorrhage&draw=2&rank=1

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator 

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

PREMIER (Prospective Study on Embolization Of Intracranial Aneurysms With Pipeline™ Embolization Device

Status: Closed and completed

Sponsor: Medtronic Neurovascular Clinical Affairs

Principal Investigator at UK: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Purpose: The purpose of this clinical study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.

Condition: Intracranial Aneurysm

Study Design:

Intervention Model: Single Group Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Intervention: Device: Pipeline™ Embolization Device/ Pipeline™ Flex Embolization Device

Study Arms: Experimental: Pipeline™ Embolization Device - treatment with Pipeline™ Embolization Device

Other information: ClinicalTrials.gov ID # NCT02186561

https://clinicaltrials.gov/ct2/show/record/NCT02186561?term=premier&rank=8

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator 

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

FEAT (Framing Eighteen Coils in Cerebral Aneurysms Trial)

Status: Closed

Sponsor: Vanderbilt University Medical Center

Collaborator: Stryker Neurovascular

Principal Investigator at UK: Justin F. Fraser, MD, Department of Neurosurgery, University of Kentucky

Purpose: FEAT is a prospective, randomized trial comparing angiographic outcomes in patients receiving large diameter coils versus those treated solely with coils with a standard diameter.Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0.014-0.0155" platinum coils during embolization compared to those receiving smaller-diameter coils.

Condition: Cerebral Aneurysm

Study Type: Interventional

Study Design: RandomizedIntervention Model: Parallel Assignment  Masking: None (Open Label)Primary Purpose: Treatment

Intervention:

• Study Procedure: Coil Embolization with larger Diameter Coils (‘Eighteen’)

• Control Procedure: Coil Embolization with standard Diameter Coils

Study Arms:

• Active Comparator: Eighteen Coils (0.014-0.0155 inch)

Subjects who randomize to this arm will receive larger diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target XL 360 Standard, Target XL 360 Soft, Target XL 360 Helical, GDC-18 360 Standard, GDC-18 3D, GDC-18 2D, GDC-18 Soft, and/or 0.014-0.0155 inch diameter bare platinum intracranial coils.Intervention: Procedure: Coil Embolization with larger Diameter Coils

• Active Comparator: Standard Coils (0.014 inch)

Subjects who randomize to this arm will receive the standard diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target 360 Standard, Target 360 Soft, Target 360 Ultra, Target 360 NANO, Target 360 Helical Ultra, GDC-10 360 Standard SR, GDC-10 360 Soft SR, GDC-10 UltraSoft, GDC-10 3D, GDC-10 2D, GDC-10 Soft 2D SR, GDC-10 Soft SR, GDC-10 Soft, and/or any additional 0.014 inch or less diameter bare platinum intracranial coils.Intervention: Procedure: Coil Embolization with Standard Diameter Coils

Other information:ClinicalTrials.gov ID # NCT0165578

https://clinicaltrials.gov/ct2/show/record/NCT01655784?term=FEAT&rank=1

Contact: Jennifer Isaacs, UK Neurosurgery Clinical Research Studies Coordinator

Email: jennifer.isaacs@uky.edu Phone: (859) 323-4738

Team Members:

• Justin Fraser, MD
• Jennifer Issacs
• Stephanie Morris
• Travis Sexton, PhD
• Lindsey Parker
• Hilary McCord