Clinical 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. 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.
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.
Brain Aneurysm Trials
NEXT Trial: Contour Neurovascular System™ ContiNued AccEss Investigational Device EXemption (IDE) Trial (NEXT)
Sponsor: Cerus Endovascular, Inc. / Stryker Neurovascular
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 Clinical Trials.Gov link for more details: https://clinicaltrials.gov/search?cond=Aneurysm,%20Intracranial&term=NEXT%20
ELEVATE Trial: Evaluate Endovascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms with the Pipeline™ Flex Embolization Device with Shield Technology.
Sponsor: Medtronic
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-Approval Study: Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB device.
Sponsor: Microvention, Inc.
This is a study to collect clinical data on the FDA-approved WEB aneurysm device in patients treated for ruptured or unruptured brain aneurysms. See ClinicalTrials.gov for full details.
SEAL-IT Trial: SEAL™ IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial
Sponsor: Galaxy Therapeutics, Inc.
This is a trial of a new device (SEAL-IT) which is available for the treatment of wide-necked bifurcation and side-wall aneurysms in adults. This device is designed to allow the minimally invasive treatment of complex brain aneurysms in a technically straightforward, single-step procedure.
See Clinical Trials.Gov link for more information: https://clinicaltrials.gov/search?cond=Aneurysm,%20Intracranial&term=SEAL-IT&lat=40.789142&lng=-73.13496099999999&locStr=Long%20Island,%20NY&distance=369&rank=1&page=1&limit=10
Stony Brook-RAPID Aneurysm Imaging Validation Study
Investigator-Initiated
Funding: Rapid Ai
Primary objective is to validate the reliability of RAPID Ai software in cerebral aneurysm detection on brain CTA imaging at Stony Brook Medicine.
Cerebral Vasospasm HDE Device: Neva VS
Neva VS Device is FDA-approved under Humanitarian Device Exemption (HDE) status for the treatment of cerebral vasospasm in patients with subarachnoid hemorrhage due to a ruptured brain aneurysm. It is a cerebral artery dilatation device, designed to temporarily expand and dilate the spastic vessel to restore blood flow and reduce risk of stroke caused by the vasospasm. This is available at Stony Brook Medicine.
Stroke Trials
STEP: STROKENET THROMBECTOMY ENDOVASCULAR PLATFORM
Sponsor: NIH / NINDS
STEP is a randomized, multifactorial, adaptive platform trial that seeks to optimize the care of patients with acute ischemic stroke due to large or medium vessel occlusions.
See Clinical Trials.Gov link for more details: https://clinicaltrials.gov/study/NCT06289985?cond=Ischemic%20Stroke&term=STEP%20stroke%20platform&rank=1
Distals Trial: Distal Ischemic Stroke Treatment with Adjustable Low-profile Stentriever
Sponsor: Rapid Medical
This is an acute ischemic stroke study involving distal small vessels for a thrombectomy procedure utilizing the Tigertriever 13 catheter for these smaller vessels. 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.
STAR Registry: Stroke Thrombectomy and Aneurysm Registry
This is an Investigator-Initiated, unfunded, collaboration with Medical University South Carolina (MUSC) to collect data for analysis and statistics.
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.
Contact: Christine Pol, Department of Neurology (631) 444-9083
Defining How the Hyperacute Innate Immune Response in Acute Ischemic Stroke of the Elderly Affects Functional Outcomes
Investigator-initiated with funding by Stony Brook Center for Healthy Aging (CHA)
This study examines blood samples and PET imaging in acute stroke patients to determine how the immune responses following clot removal interact with age and physiology to affect patient stroke outcomes. Blood samples will be taken immediately after clot removal and PET imaging will be performed within 48 hours to measure markers of inflammation. Patients will be assessed at discharge and 90-days later to determine functional outcomes after stroke recovery.
Contact: Christine Pol, Dept. of Neurology, 631-444-9083
Non-Wearable Sensors for Monitoring Recovery after Stroke
Investigator-initiated
This is a feasibility study to determine whether contactless sensors can be used to capture a patient’s clinical and functional changes over time as they recover from stroke. Using the Stony Brook University CEWIT Home of the Future lab, patients will visit the 450-square foot, fully furnished, sensor equipped apartment for 90 minutes of data collection while they perform activities of daily living. Data will be collected 2-, 4-, and 12-weeks post-stroke.
Study status: currently under IRB review.
Contact: Tristan Vozzolo, Dept. of Emergency Medicine, 631-444-9676
Brain (Cerebral) Hemorrhage Trials
FASTEST Trial: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke
Sponsor: National Institutes of Health (NIH)
Please see this Stony Brook FASTEST link for details. See ClinicalTrials.Gov link for details: https://clinicaltrials.gov/ct2/show/NCT03496883
ASPIRE Trial: Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery.
Sponsor: National Institution of Health, NINDS
This is a research study to compare two blood thinners to determine which is better at reducing risk of stroke in patients with atrial fibrillation and a recent brain hemorrhage. See ClinicalTrials.gov for full details: https://www.clinicaltrials.gov/study/NCT03907046?cond=stroke&term=aspire&rank=3
Contact: Christine Pol, Department of Neurology (631) 444-9083
ARCH Trial: Active Removal of Intracerebral Hematoma via Active Irrigation of Ventricular System.
Investigator-Initiated, funding by IRRAS, USA Inc.
This is a study for patients who have blood clot (hematoma) in a ventricle (fluid space in the brain) that require a drain placement along with clot dissolving medication to remove the clot. The study will compare the IRRAflow Active Fluid Exchange system and the standard external ventricular drainage system (EVD). See ClinicalTrials.gov for full details.
Other
Cerebrovascular Refractory Chronic Migraine Trial: Feasibility Study to Evaluate the Initial Safety and Effectiveness of TRUFILL n-BCA Liquid Embolic System in Middle Meningeal Artery Embolization for the Preventive Treatment of Refractory Chronic Migraine.
Sponsor: Cerenovus
See Clinical Trials.gov link for details: https://clinicaltrials.gov/study/NCT06735833?cond=Refractory%20Chronic%20Migraine&rank=7
Active Trials Closed to Enrollment, But Ongoing for Follow Up
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.
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.
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.
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.
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 Clinical Trials.gov for full details.
NECC Trial: US IDE Study of the Contour NEurovascular System™ for intracranial aneurysm repair
Sponsor: Cerus Endovascular, Inc. / Stryker Neurovascular
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.
THUNDER Trial: Large Vessel Acute Stroke Study utilizing Thunderbolt™ Tubing
Sponsor: Penumbra, Inc.
This study is for acute ischemic stroke patients using the Penumbra System including Thunderbolt™ Aspiration Tubing. This tubing system includes a modulator for aspiration during a large vessel acute stroke thrombectomy procedure. See ClinicalTrials.gov for full details.
RESTORE: Real-World Analyses of Stroke-Thrombus Occlusion Retrieval.
Sponsor: Microvention, Inc.
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 specific FDA approved catheters and devices are utilized during the procedure. See ClinicalTrials.gov for full details.
MARRS Trial: Millipede Aspiration for Revascularization in Stroke Study
Sponsor: Perfuze
This is an acute ischemic stroke study utilizing large diameter Millipede System catheters for large vessel -large clot strokes during a thrombectomy procedure.
FRED-X -PAS: Flow Re-Direction Endoluminal Device X (FRED X) Post Approval Study.
Sponsor: Microvention, Inc.
This is a study to collect clinical data on the FDA-approved FRED X™ flow diverter device for unruptured brain aneurysm treatment in adults.
