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
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.
The ARTISSE™ Intrasaccular Device is indicated for the treatment of wide-neck bifurcation intracranial aneurysms.
Protocol MDT24004.
Sponsor: Medtronic.
This is a trial of a new device (ARTISSE) 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.
See Clinical Trials.gov ID NCT02998229 https://clinicaltrials.gov/study/NCT02998229?cond=Aneurysm%20Cerebral&term=ARTISSE%20&viewType=Card&rank=1#contacts-and-locations
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms with Surpass Elite with GUARDian Flow Diverter.
Protocol CDM10001836
Sponsor: Stryker Neurovascular
This is a trial of a new surface modified flow-diverter device (GUARD) which is available for treatment of sidewall cerebral aneurysms in a minimally invasive procedure.
See Clinical Trials.gov ID NCT06872684 https://clinicaltrials.gov/study/NCT06872684?cond=Aneurysm%20Cerebral&term=Guardian&viewType=Card&rank=1#contacts-and-locations
p48/64 MW HPC in Aneurysm Occlusion (PIANO): Prospective, multicenter, single-arm clinical trial to determine safety and effectiveness of the flow modulation device in the treatment of wide-necked intracranial aneurysms.
Protocol: pCT-002-23
Sponsor: phenox, Inc.
This is a trial of a new surface modified flow-diverter device (p48 or p64 MW HPC devices) which is available for treatment of sidewall cerebral aneurysms in a minimally invasive procedure.
See Clinical Trials.gov ID NCT07143019 https://clinicaltrials.gov/study/NCT07143019?cond=Aneurysm%20Cerebral&term=piano&viewType=Card&rank=1
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
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
Functional Outcomes in Real-World Treatment and Revascularization of Non-dominant and Distal M2 Occlusions. Protocol CLP33727.
Sponsor: Penumbra, Inc.
This is a study to collect clinical data on the commercially available Penumbra System Reperfusion Catheters in treatment of acute ischemic stroke in certain brain vessels as well as collect clinical data on this stroke patient population who are medically managed.
See Clinical Trials.gov ID NCT07749170 https://clinicaltrials.gov/study/NCT07749170?cond=Ischemic%20Stroke&term=FORWARD%20&viewType=Card&rank=1
Treatment with Endovascular Intervention for Stroke Patients with Existing Disability
Funding: Patient Centered Outcomes Research Institute (PCORI)
This is a prospective, observational study of acute ischemic stroke patients with a pre-existing moderate to severe disability.
See Clinical Trials.gov ID NCT05911568 https://clinicaltrials.gov/study/NCT05911568?cond=Ischemic%20Stroke&term=TESTED&viewType=Card&rank=1
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
PHIL™ (Precipitating Hydrophobic Injectable Liquid) Middle Meningeal Artery Embolization (MMAE) for First-Line Treatment of Chronic Subdural Hematoma (cSDH)
Protocol: CL1108390
Sponsor: Microvention, Inc.
This is a trial in patients with non-emergent chronic subdural hematoma requiring treatment and comparing the minimally invasive embolization procedure using PHIL liquid embolic or Onyx liquid embolic.
See Clinical Trials.gov ID NCT07576998 https://clinicaltrials.gov/study/NCT07576998?cond=cSDH&term=phil%20first&viewType=Card&rank=1
Active Trials Closed to Enrollment, But Ongoing for Follow Up
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.
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.
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.
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.
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
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
