As Suffolk County's only academic medical center, we are dedicated to advancing the newest, safest and most innovative treatments for cerebrovascular disease. Many of these treatments are only available within the context of ongoing clinical research trials. Clinical trial sponsors frequently seek out our Cerebrovascular Center as a trial site, often making Stony Brook Medicine the first on Long Island or in the country to offer treatment options not available elsewhere.
We have two dedicated, certified research nurse coordinators, Marlene Baumeister, RN, and Dawn Madigan, RN, who are responsible for maintaining and implementing these research protocols and assisting patients (and families of patients) who are participating in these trials. We are currently participating in more than 15 active clinical research trials. If you are a patient and you think you may qualify for one of our ongoing research trials, please contact Marlene or Dawn, at (631) 444-8121 or (631) 444-1610.
We offer clinical trials for:
BRAIN ANEURYSM TRIALS
NECC Trial
US IDE Study of the Contour NEurovascular System™ for intracranial aneurysm repair.
Sponsor: Cerus Endovascular, Inc.
This is a trial of a new device (Contour) which is available for the treatment of wide-necked bifurcation aneurysms in adults. This device is designed to allow the minimally invasive treatment of complex brain aneurysms in a technically straightforward, single-step procedure. Many patients with this type of aneurysm, which would normally require open brain surgery or complex endovascular procedures to treat, are potentially eligible for treatment within this study for this new minimally invasive therapy. Stony Brook Medicine is the only center on Long Island participating in this trial. See ClinicalTrials.gov for full details.
ELEVATE Trial
Evaluate Endovascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms with the Pipeline™ Flex Embolization Device with Shield Technology.
Sponsor: Cerus Endovascular, Inc.
This is a trial of a new surface modified flow-diverter device (Pipeline™ Flex Embolization Device with Shield Technology) which is available for treatment of ruptured blister aneurysms which are not amenable to surgical clipping or coiling. Stony Brook Medicine is the only center on Long Island participating in this trial. See ClinicalTrials.gov for full details.
WEB-PAS
Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB® Device.
Sponsor: Microvention, Inc.
This is a registry collecting data on adult patients who are treated with the WEB Device for a cerebral aneurysm. See ClinicalTrials.gov for full details.
FRED-X-PAS
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post Approval Study. Sponsor: Microvention, Inc.
Sponsor: Microvention, Inc.
This is a registry collecting data on adult patients who are treated with the FRED-X Device for a cerebral aneurysm. See ClinicalTrials.gov for full details.
STROKE TRIALS
SoFAST / RESTORE
This is a registry collecting data on adult patients who present with an acute ischemic stroke from anterior circulation emergent large vessel occlusion and undergo emergency clot removal (i.e thrombectomy). The registry collects information when a specific FDA approved Microvention, Inc catheter or other devices are utilized during the procedure. See ClinicalTrials.gov for full details.
VR REHAB Trial
Improving Functional and Cognitive Outcomes after Ischemic Stroke using Virtual Reality Based Rehabilitation.
Investigator-initiated
This is a prospective randomized control pilot study for adult patients who present with an ischemic stroke. In this trial, a patient undergoes motor challenges while connected to virtual world wearing a headset and sensors under the observation of physical or occupational therapist. The aim of the study is to examine the feasibility and effectiveness of virtual reality therapy for stroke recovery.
DISTALS
Distal Ischemic Stroke Treatment with Adjustable Low-profile Stentriever (DISTALS).
Sponsored by Rapid Medical.
This study aims to evaluate the safety and effectiveness of the Tigertriever 13 device compared to standard medical management in the treatment of a distal vessel stroke. See ClinicalTrials.gov for full details.
THUNDER
Acute Ischemic Stroke Study with the Penumbra System® including Thunderbolt™ Aspiration Tubing.
Sponsored by Penumbra, Inc.
This study aims to evaluate the safety and effectiveness of the Penumbra System including Thunderbolt Aspiration Tubing in the treatment of a large vessel stroke. See ClinicalTrials.gov for full details.
MARRS
Millipede Aspiration for Revascularization in Stroke Study.
Sponsored by Perfuze.
This study aims to evaluate the safety and effectiveness of the Millipede System in the treatment of a large vessel stroke. See ClinicalTrials.gov for full details.
Innate Immunity in Human Stroke
Defining how the Hyperacute Innate Immune Response in Acute Ischemic Stroke of the Elderly Affects Functional Outcomes.
Funding by Center for Healthy Aging (CHA).
This is an investigator-initiated study to evaluate how age-related changes in the immune system affect the brain’s response to acute ischemic stroke and may influence the recovery process. Blood samples would be collected and brain imaging performed for analysis in this trial on participating stroke patients who receive thrombectomy for their treatment. For more information contact Dr. Neil Nadkarni, Neurology Department.
Non-Wearable Sensors for Monitoring Recovery after Stroke
Funding by an SBU Targeted Research Opportunity Fusion Award
This investigator-initiated study will use low-cost contactless sensors to determine the feasibility of capturing physiological parameters and changes in motor function over time in patients discharged home after hospitalization for acute ischemic stroke. We will utilize a multidisciplinary research team and scripted visits at SBU CEWIT “Home of the future”, a sensor outfitted junior one bedroom apartment located a short distance from Stony Brook University Hospital. Data from this study will be used to develop algorithms for home-based installation of our sensor system to monitor stroke patients post hospitalization. For more information contact Dr. Jason Mathew, Neurology Department.
STEP Stroke Platform
StrokeNet Thrombectomy Endovascular Platform.
Sponsored by National Institutes of Health (NIH) / National Institutes of Neurological Diseases (NINDS)
This is a multicenter platform for multiple acute stroke projects and trials that involve FDA-approved, commercially available devices for thrombectomy procedures along with standard stroke care at our comprehensive certified stroke center. See ClinicalTrials.gov for full details.
Mobile Stroke Unit Data Registry
MSU data collaboration with Cleveland Clinic MSU.
Investigator-initiated
This is a data collection study of stroke patients who receive care on one of our Mobile Stroke Units. We are combining our data with data from the Cleveland Clinic. This study is designed to help us learn more about the impact of the MSU program on stroke outcomes and to determine ways in which to further optimize and improve stroke outcomes.
BRAIN (CEREBRAL) HEMORRHAGE TRIALS
ARCH Trial
Active Removal of IntraCerebral Hematoma via active irrigation of ventricular system.
Sponsored by IRRAS.
This is an investigator -initiated, international prospective, controlled, randomized, open label multicenter study. This study aims to evaluate the FDA approved IRRAflow® Active Fluid Exchange System in the clearance of intraventricular hemorrhage compared with passive drainage (standard external ventricular drain, “EVD”). See ClinicalTrials.gov for full details.
FASTEST
rFVIIa for Acute hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial.
Sponsored by National Institutes of Health (NIH).
This multicenter trial aims to evaluate if the medicine, Recombinant Factor VIIa, improves outcomes in stroke patients that have a hemorrhage (bleeding) stroke. See ClinicalTrials.gov for more details and https://neuro.stonybrookmedicine.edu/FASTESTtrial.
ACTIVE TRIALS CLOSED TO ENROLLMENT, BUT ONGOING FOR FOLLOW UP
C-Guardians Pivotal IDE Trial
A Multicenter, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the CGUARD™ Carotid Stent System when used to Treat Symptomatic and Asymptomatic Carotid Artery Stenosis in Patients Undergoing Carotid Artery Stenting.
Sponsor: Inspire MD, LTD
This is a trial for adult patients who have a diagnosis of carotid artery stenosis (symptomatic or asymptomatic) who require a carotid artery stent. Enrollment to open soon at our site. Stony Brook Medicine is the only center on Long Island participating in this trial. See ClinicalTrials.gov for full details.
Performance II Trial
Protection against Emboli during Carotid Artery Stenting using a 3-in-1 Delivery System Comprised of a Post-dilation balloon, integrated embolic filter and a Novel Carotid Stent II.
Sponsor: Contego Medical
This is a trial for adult patients who have a diagnosis of symptomatic or asymptomatic carotid artery (blood vessel in the neck) stenosis (narrowing) who require a carotid artery stent. Stony Brook Medicine is the only center on Long Island participating in this trial. See ClinicalTrials.gov for full details.
STERLING
Registry of Micrusframe and Galaxy Coils for the endovascular treatment of intracranial aneurysms.
Sponsor: Cerenovus
This is a registry collecting data on adult patients with either ruptured or unruptured aneurysms treated with FDA-approved Micrusframe and/or Galaxy coils. See ClinicalTrials.gov for full details.
EVOLVE Trial
Endovascular Treatment of Wide-Neck Aneurysms, an Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System.
Sponsor: Stryker Neurovascular
This is a trial of a new FDA-approved flow-diverter device (Evolve Surpass) which is available for treatment of wide-necked brain aneurysms in adults. A second smaller version of the device (Darwin EVOLVE 40W) is investigational and available only within the trial. The Darwin EVOLVE 40W device is specifically engineered for the treatment of wide-necked brain aneurysms arising from smaller blood vessels (between 2 and 3.5 mm in diameter). The EVOLVE trial is specifically evaluating aneurysms that are < 12mm in size in adults. Stony Brook Medicine is the only center on Long Island participating in this trial. See ClinicalTrials.gov for full details.
RECENTLY CLOSED TRIALS AT OUR SITE
COAST
Coiling of Aneurysms Smaller than 5mm with Hypersoft coils.
Sponsor: M.U.S.C with funding by Microvention, Inc.
See ClinicalTrials.gov for full details.
RAGE
Ruptured Aneurysms Treated with Hydrogel.Coils. Semmes-Murphey Foundation
Sponsor: Microvention, Inc.
This is a registry collecting data on adult patients with ruptured aneurysms treated FDA-approved hydrogel coils. See ClinicalTrials.gov for full details.
ADVANCE
Pipeline™ Vantage Embolization Device with Shield Technology for endovascular treatment of wide-necked intracranial aneurysms.
Sponsor: Medtronic.
See ClinicalTrials.gov for full details.
CONFIDENCE Trial
Carotid Stent Trial to Evaluate the Safety and Efficacy of the Roadsaver™ Stent Used in Conjunction with the Nanoparasol® Embolic Protection System for Patients at Increased Risk for Adverse Events from Carotid Endarterectomy.
Sponsor : MicroVention,Inc.
See ClinicalTrials.gov for full details.
CREST-2 Trial
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) Protocol.
Sponsor: National Institution of Health, NINDS
This is a trial for adult patient who have a diagnosis of carotid artery stenosis without symptoms of stroke. Patients in this trial may be treated with carotid stenting or carotid endarterectomy. See ClinicalTrials.gov for full details.
STEM
The Squid Trial for the Embolization of the Middle Meningeal Artery (STEM) for Treatment of Chronic Subdural Hemorrhage.
Sponsor: Balt, USA
This is a prospective, randomized, controlled trial for adult patients with a diagnosis of chronic subdural hematoma (cSDH). This pivotal trial examines the safety and effectiveness of middle meningeal artery (MMA) embolization with a new, investigational, liquid embolic agent (i.e., a glue like material) called “Squid” in patients with symptomatic chronic subdural hematoma. Stony Brook Medicine is one of two leading sites in this international, multicenter trial. Stony Brook Medicine is the only center on Long Island participating in this trial. See ClinicalTrials.gov for full details.
MIND Trial
A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage.
Sponsor: Penumbra, Inc.
This is a trial for adult patients who present with a hemorrhage stroke (spontaneous bleeding into the brain). This trial utilizes a new FDA-approved device, Artemis, for blood clot / hematoma removal using minimally invasive endoscopic neurosurgical technique. Stony Brook Medicine is the only center on Long Island participating in this trial. See ClinicalTrials.gov for full details.
H2M Trial
Pilot study of the neuroprotective effects of hydrogen and minocycline in acute ischemic stroke.
Investigator-initiated
This is a pilot randomized control trial for adult patients who present with an acute ischemic stroke. The trial explores the possible beneficial effect of a novel combination therapy consisting of molecular hydrogen H2 plus minocycline ("H2M"), on neurological recovery. See ClinicalTrials.gov for full details.
INSIGHT
Investigation of Clot in Ischemic Stroke and Hematoma Evacuation.
Sponsor: Penumbra, Inc.
This trial is designed to analyze the composition of the clots removed from the blood vessels of patients experiencing ischemic strokes from emergent large vessel occlusions. So after a thrombectomy procedure is performed, the extracted blood clots are sent for a series of sophisticated analyses. The aim of the study is to learn more about the blood clots that cause this ischemic stroke. This trial also will analyze the composition of blood clots removed from patients who have experienced brain bleeds. See ClinicalTrials.gov for full details.
US WEB-it Trial
The WEB Intrasaccular Therapy Study.
Sponsor: Sequent Medical, Inc. / Microvention, Inc.
A trial for wide-neck bifurcation brain aneurysms. Stony Brook was one of two lead centers in the world for this international multi-center trial. Stony Brook Medicine was the only center on Long Island participating in this pivotal trial. See ClinicalTrials.gov for full details.
VITAL Trial
The VESALIO™ Neva VS for the Treatment of Symptomatic Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage (aSAH).
Sponsor: Vesalio.
This trial utilized a new endovascular device to treat cerebral vasospasm in patients with ruptured aneurysms. See ClinicalTrials.gov for full details.