Clinical Trials

The purpose of this research is to determine whether we can identify when changes in blood vessel shape over time are likely to occur, and to what extent those changes can be predicted by MRI studies. In order to determine that, we wish to investigate these methods in subjects who have aneurysmal disease.

The purpose of this study is to evaluate different techniques to repair internal iliac artery aneurysms. Report short and long term clinical outcomes with markers of pelvic perfustion.  Compare partial pelvic perfusion preservation with bilateral complete preservation.

The PRESERVE-Zenith® Iliac Branch Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™/Atrium iCAST™ covered stent in the treatment of aorto-iliac and iliac aneurysms.

The purpose of this study is to determine the safety and effectiveness of the WEB Aneurysm Embolization System for the treatment of WNBAs located in the anterior (middle cerebral artery (MCA) bifurcation, internal carotid artery terminus (ICAt) or anterior communicating artery complex (ACom) and posterior (basilar apex) circulations.

The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.

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.

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.

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.

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.

The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).

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.

The purposes of this study are to determine temporal changes in patient reported outcomes and quality of life (QOL) associated with EVAR, factors associated with requirement for reintervention after EVAR, and the effect of reinterventions on patient reported outcomes and QOL associated.

The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta (DTA).

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 ...

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 ...

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 ...

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.

This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.

The purpose of this study is to compare the utilization of healthcare resources between open surgical and endovascular repair of infrarenal abdominal aortic aneurysms. 

The purpose of this study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta.

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms.  

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects will be randomized and imaging will be collected at all follow-up time points to assess the primary endpoint.

The purpose of this study is to compare the effectiveness and safety of EG-1962 to the standard of care oral nimodipine for the treatment of adult patients who have an aneurysmal subarachnoid hemorrhage.

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 ...

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.

The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS) for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence of cerebral vasospasm.

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.

The purpose of this study is to determine the effectiveness of Basis™ (Nicotinamide Riboside and Pterostilbene) in preventing acute kidney injury (AKI) among patients undergoing complex aortic aneurysm repair and aortic arch reconstruction.

Prospective, non-randomized, , multicenter study with two independent arms: * Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. * Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only * Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)

The study is being done to compare radiation exposure between two standard-of-care methods of abdominal aortic aneurysm repair.

The purpose of this study is to evaluate Endologix AFX endovascular abdominal aortic aneurism system with anatomical fixation against other approved endovascular systems with proximal fixation.

The purpose of this study is to determine the feasibility of using SSPGB to reduce the self-reported headache pain that patients with aneurysmal SAH experience during their hospital admission.

The purpose of this study is to determine if cytochrome P450 (CYP) enzyme family variants alter the body's metabolism of nimodipine after Aneurysmal Subarachnoid Hemorrhage (aSAH), and if actual levels of nimodipine correlate with clinical events and patient outcomes.

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.

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.

This is a prospective, non-randomized, single center, data collection study of patients treated with open surgical repair (OR) for complex aortic aneurysms (CAAs).

Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic ...

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.

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.

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 ...