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Ischemic Preconditioning Prior to Cerebrovascular Interventional Procedures
Rochester, MN
The purpose of this study is to determine if patients receiving Remote ischemic conditioning (RIC) prior to elective endovascular treatment of intracranial aneurysms will have a reduction in rates of cerebral ischemia as detected onimaging when compared to a group of historical controls. Our secondary aim is to determine if patients who receive ischemic preconditioning have any elevation in serum markers for cerebral ischemia.
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A Study of the Clinical Presentation and Natural History of Vertebrobasilar Non-Saccular and Dolichoectatic (Types of Symptom and Brain Location) Aneurysms
Rochester, MN
The purpose of this study is to learn more about why and what influences these types of brain aneurysms to form, grow or rupture. We will be looking at factors such as medical problems, medications, lifestyle factors and how they may be a role.
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Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms
Jacksonville, FL; Rochester, MN
This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left untreated, the bulge may continue to grow larger and ultimately the vessel may break open (rupture), resulting in serious bleeding into our around the brain. The information collected from this study will be used to evaluate how well patients do ...
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Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System (EVOLVE)
Jacksonville, FL
The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches.
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Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage
Jacksonville, FL
The purpose of this study is to see how much gabapentin will reduce headaches associated with subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication prescribed.
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Prospective Study on Embolization of Intracranial Aneurysms with Pipeline™ Embolization Device
Rochester, MN
The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.
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The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
Jacksonville, FL
To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck, saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath and a delivery wire assembly. The implant component is made of superelastic and biocompatible nitinol tubular material. Patients presenting with wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA) from the cavernous segment to the carotid ...
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Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.
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miRNA Expression in Aneurysm Healing
Rochester, MN
The purpose of this study is to determine if vascular remodeling may be impacted by concomitant coiling with flow diverter therapy. We will compare micro-RNA markers between groups of patients treated with and without concomitant coiling with flow diversion therapy.
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Aneurysm Treatment Using Flow Diverter
Rochester, MN; Jacksonville, FL
The objectives of this study are to develop a repository of three-dimensional computerized tomography angiography (3DCTA) and three-dimensional rotational angiography (3DRA) imaging data and blood specimen collected from patients at pretreatment, post-treatment, and follow up, to monitor and identify the patients who have in-stent thrombosis, device mal-apposition, distal stroke, or other ischemic complications, to correlate fibrinogen levels, platelet activation, and thrombin generation with outcomes and to compare circulating miRNA and protein profiles and computational fluid dynamic (CFO) based hemodynamics and thrombosis initiation maker variables of patients who had ischemic complications versus those who did not.
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A Study of the Role Connective Tissue and Wound Healing Characteristics Play in Patients with Multiple Brain Aneurysms
Rochester, MN
The purpose of this study is to develop an increased understanding of the role of connective tissue structural abnormalities and impaired function (i.e. wound healing) in the development of intracranial aneurysms.
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Hydrogel Endovascular Aneurysm Treatment Trial
Jacksonville, FL
This research study is being done to test the effectiveness of a new generation FDA approved device for treating aneurysms compared to the current standard device for endovascular aneurysm treatment which is bare platinum coils. Endovascular procedures are a form of minimally invasive surgery, which is performed on blood vessels. The technique involves the introduction of a catheter which is a long, thin, flexible, hollow plastic tube through the skin into a large blood vessel. Typically the chosen blood vessel is the femoral artery found near the groin. The catheter is then maneuvered through the body to the location of ...
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A Study of Human Placenta as a Model for Microsurgical Aneurysm Clipping
Rochester, MN
The purpose of this study is to obtain human placentas from obstetric patients giving birth at Mayo Clinic. We then plan to produce model aneurysms within the placentas using a validated methodology. Model placentas will then be used for training purposes in a microsurgical lab available to all neurosurgical residents.
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A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
Rochester, MN
This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.
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A Study of Computer Simulation of Endovascular Repair of Cerebral Aneurysms Aneurysms
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study will look at how a new investigational software program, called the Endovantage Interventional Suite (EVIS), can help your doctor better plan surgeries like yours through computer simulation. The software allows your doctor to see how the chosen medical device(s) will perform when it is placed in the blood vessel in your brain. We hope to determine if the computer simulation is realistic and indeed accurately shows your doctor exactly what happened at the time of surgery. If the computer simulation is an accurate reflection of the actual surgery, then the software could help your doctor take better care ...
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Brain and Abdominal Aneurysm Study
Jacksonville, FL; Rochester, MN
Aneurysmal subarachnoid hemorrhage (aSAH) is the most deadly kind of stroke. Each year, 40,000 Americans have SAH. Case-fatality approaches 60% and more than half of those who die do so before reaching the hospital. Most commonly, SAH results from rupture of an intracranial aneurysm. Screening high-risk individuals could identify those at greatest risk and decrease the devastating effect of SAH. Aortic Aneurysm also constitutes a major public health problem with high lethality. Current estimates are that ruptured aortic aneurysm kills 13,000 Americans each year. Screening efforts have effectively lowered mortality from aortic aneurysm rupture but a high proportion of those ...
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Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
Jacksonville, FL
The primary objective of this study is to gather post market data on the Penumbra SMART Coil™ System in the treatment of intracranial aneurysms and other malformations.
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A Study of Simulated Sylvian Fissure Dissection Under Subarachnoid Hemorrhage Conditions Using a Rodent Microvascular Anastomosis Model
Rochester, MN
The purpose of this study is to assess the differences in microvascular anastomosis outcomes between the experiment aneurysmal subarachnoid hemorrhage (aSAH)-like conditions and control animals.
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Intraventricular Nicardipine for Aneurysmal Subarachnoid Hemorrhage Related Vasospasm: Assessment on Clinical Outcomes of Stroke by 30 & 90 Days
Jacksonville, FL
The purpose is to study the effects of intraventricular nicardipine, a vasodilatory agent, on VP and secondary outcomes of stroke and functional outcome at 30 and 90 days compared to those not treated with this agent.
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Feasibility Study Comparing the Utility of GLOW800 and FL800 Intraoperative ICG-VA Tools for Intracranial Lesions
Scottsdale/Phoenix, AZ
The purpose of this study is to comparatively evaluate the use of the GLOW800 visualization tool for ICG-VA versus the standard of care visualization tool FL800.
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A Study to Assess if Using Holography/Augmented Reality and 3D-printed Models to Visualize Intracranial Diseases and Aid in Patient Education
Scottsdale/Phoenix, AZ
The purpose of this study is to assess if using holography/ Augmented Reality and 3D-printed models to visualize intracranial diseases and aid in patient education.
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Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain, Caused by Bleeding Onto the Surface of the Brain (REACT)
Jacksonville, FL
The purpose of this study is to evaluate if clazosentan (on top of normal routine medical care) can reduce the risk of developing complications related to cerebral vasospasm and permanent brain damage as compared to normal routine medical care alone.
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Florida Cerebrovascular Disease Biorepository and Genomics Center
Jacksonville, FL
The aim of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida. The Center will collect and store detailed phenotypic information, DNA, and other biofluids on affected subjects with diverse cerebrovascular conditions, including, but not limited to, ischemic stroke, transient ischemic attack (TIA), intracerebral hemorrhage (ICH), aneurysmal subarachnoid hemorrhage (aSAH), vascular dementia (VAD), anoxic brain injury, unruptured intracranial aneurysm (UIA), cavernous malformation, arteriovenous malformations (AVM), carotid and vertebral arterial dissections, symptomatic and asymptomatic cervical carotid artery atherosclerotic stenosis, non-aneurysmal perimesencephalic subarachnoid hemorrhage (naSAH), cerebral venous thrombosis (CVT), moyamoya disease, fibrosmuscular dysplasia (FMD), non-traumatic, angiography-negative subarachnoid ...