This study is for patients that have Critical Limb Ischemia (CLI), a form of Peripheral Arterial Disease (PAD) in which an artery (blood vessel) in their lower leg (calf) may have become blocked. This study involves the use of an investigational devices called a stent (a small mesh tube typically used to hold open blood vessels). The study device (stent) that will be used in this study is called the Bare Temporary Spur Stent System. It is intended to be used for treatment of Critical Limb Ischemia (CLI). The stent portion is made of nitinol, a metal commonly used in stents. It is unique from other similar approved devices, such as balloons and stents, because it consists of a delivery system that can deliver and re-capture the Bare Temporary Spur Stent and balloon, so that no metal is left behind in the body. The Bare Temporary Spur Stent has small spurs (spikes) on the outer surface of the stent, which pierce the inner lining of the artery. Together, the spurs and the stent may help to support the artery as it rebounds after the balloon inflation. The purpose of this is to help the artery stay open so that there is a channel for blood flow to the foot.
The study is to evaluate real world usage of the ENROUTE® Transcarotid Stent System when used with the ENROUTE® Transcarotid Neuroprotection System in patients with significant carotid artery disease who are at standard risk for adverse events from carotid endarterectomy (CEA). The devices used in the study are not investigational and have been approved for use by the Food and Drug Administration (FDA).
The purpose of this research study is to find out if AMDS is safe and effective in the treatment of acute dissection (sudden tear). For patients whose aortic anatomy is suitable for treatment with AMDS, the use of this device may promote healing of the aortic walls and possibly reduce the need for additional aortic surgeries. If conventional surgery, in combination with AMDS, is effective, it is believed that this could lead to improved aortic healing; an improvement in healing could reduce the risk of hospitalization and reoperation in the chest compared to conventional surgery alone.
The types of balloons being studied in this clinical study is similar to other balloon devices that are routinely used in angioplasty procedures; however, it has a unique technology inside the balloon which is designed to deliver sonic energy (sound) to disrupt the hard, calcified elements of vascular blockages. With the balloon inflated at a low pressure, the probe will be activated to disrupt the calcium that is restricting the expansion of the artery.
This study will compare WATCHMAN FLXTM ("DEVICE") to a category of OAC called non-vitamin K antagonist oral anticoagulation, also known as NOACs ("CONTROL"). NOAC medications include Pradaxa® (dabigatran), Eliquis® (apixaban), Xarelto® (rivaroxaban), or Savaysa® (edoxaban).The study will research the safety and effectiveness of the WATCHMAN FLXTM device compared to treatment with NOAC therapy to determine if it works for patients with your type of atrial fibrillation who require treatment for potential blood clot formation (thrombus) in the LAA.
The purpose of this research study is to continue to test how well the Endospan NEXUSTM Aortic Arch Stent Graft System performs in the treatment of a diseased aortic arch. The aortic arch is the top part of the main large vessel that carries blood away from the heart. A stent graft is a self-expanding frame that is covered with a material intended to seal the vessel walls.
The NEXUS Aortic Arch Stent Graft System is delivered to the diseased area of your aorta by traveling through your vascular system using fluoroscopic guidance (x-ray pictures), starting with a small incision or needle puncture near your groin (inner thigh). The NEXUS Aortic Arch Stent Graft System is being studied and is not approved by the FDA which means it is investigational in this study. The NEXUS Aortic Arch Stent Graft System has CE Mark which means it is approved for use in Europe. The NEXUS Aortic Arch Stent Graft System is only available through the clinical study in the United States.
The purpose of this research study is to develop a better understanding of the cause and natural history of vascular anomalies and related syndromes. This study is being done in order to develop a better understanding of the cause of vascular anomalies in order to to improve care for people who are affected by these anomalies and related syndromes.
This study is being done at the University of Wisconsin-Madison (UW-Madison) and other sites in North America and Europe. A total of about 1000 people will participate in this study. About 20 – 30 people will take part in the study here at the Medical University of South Carolina.
In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. The purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. Additionally, the study will evaluate patient satisfaction and identify adverse effects. Participants will be on the medication for 6 months with an option to continue after this time period.
This is a prospective cohort study of subjects with portal hypertension to examine whether increased sphingosine 1 phosphate : ceramide ratio and circulating bile acids are associated with HPS in patients with advanced liver disease. The study will consist of 400 individuals who are evaluated for liver transplantation at the Field Centers. This population has advanced liver disease and will represent the population with cirrhosis at the Centers. As is considered standard of clinical care for these patients and required for liver transplant evaluation, patients will undergo phlebotomy, interviews, pulmonary function testing, echocardiography, and arterial blood gas sampling at their initial evaluation. During the clinical phlebotomy, additional samples will be drawn for research purposes. If any of these procedures does not occur during the clinical visit, it may be conducted for research purposes. Six minute walk testing, frailty scales, SF36, and optional actigraphy, all of which are research-only assessments, will be performed at baseline. Subjects will then be followed via phone for the duration of the study period.