This purpose of this study is to evaluate a new device called Lava Liquid Embolic System (LES) in the treatment of peripheral arterial hemorrhage (active bleeding in vessels outside of the head, heart, spine, and vessels related to childbirth). As an investigational device, Lava LES is not FDA approved.
The Lava LES device provides a minimally invasive type of treatment inside the vessels called embolization therapy that reduces or blocks blood flow to blood vessels or organs in order to stop internal bleeding. Subjects who have hemorrhage (bleeding) in a peripheral artery, including arteries located in the gastrointestinal system (stomach, intestines), lungs, liver, pancreas, spleen, prostate, bladder, uterus, muscles, or other peripheral artery wound caused by medical intervention or trauma, may be eligible for treatment with Lava LES.
The primary effectiveness goal is clinical success. Clinical success is defined as absence of bleeding from the wounded vessel after embolization with the Lava LES, without the need for emergency surgery, repeat embolization, or other medical intervention at the wounded vessel within 30 days of the embolization procedure. Subjects will be evaluated for 30 days following the embolization procedure for complications or side effects that may be related to the procedure and/or Lava LES device. The primary safety endpoint is freedom from major adverse events for 30 days. This is a first-in-human investigational trial.
Subjects will complete 4 visits (screening, embolization procedure, discharge, and 30-day follow-up). The 30-day follow-up will be completed remotely (video call or phone call). Some visits may occur on the same day. Participation in the study is anticipated to last about 30 days following the embolization procedure.
The purpose of this research study is to gather information on the health outcomes of patients who receive treatment with the Shockwave Medical, Inc Peripheral Lithoplasty® (Shockwave device) to assist with aortic endovascular procedures requiring a large catheter (long, thin tube made from medical grade materials). An endovascular procedure is a procedure where a doctor uses a small cut to insert a catheter into a blood vessel to repair it. The Shockwave Medical, Inc Peripheral Lithoplasty® system is an FDA approved catheter device used to open narrowed blood vessels in the legs (called arteries) so that it is easier for blood and other catheters to pass through. This study will collect information from participants who need an endovascular procedure on their aorta. The small cut used to insert the catheter is usually made in an artery in your leg and is used to get to your aorta. Endovascular procedures on the aorta use large catheters. Sometimes, it is necessary to expand the blood vessel in your leg so that the large catheters can fit. There are many different methods used clinically for this purpose, but it is not known which method works best. This study will help to determine if using the Shockwave device to expand your blood vessel is a better than using balloon angioplasty (use of a catheter with a balloon on the end) to expand your vessel
This study is seeking participants with narrowing of the blood vessels of their lower limbs. The purpose of this study is to determine if treating a blockage in blood vessel in the leg has a better long term outcome when placing a stent like device called a scaffold that is coated with a medication after ballooning open the vessel compared to opening the vessel with the balloon only. The scaffold device is called the Esprit™BTK Everolimus Eluting Bioresorbable Scaffold System and is considered investigational meaning it has not been approved for commercial use by the US Food and Drug Administration. The study is designed to last 5 years and will include up to 10 visits.
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 study aims to investigate the safety and effectiveness of the Instylla Hydrogel Embolic System (HES) compared to the standard of care TAE/cTACE to treat a tumor by reducing or completely closing off the arterial blood supply to the tumor. The Instylla HES is an experimental treatment. Subjects will be evaluated for 180 days following the embolization procedure. At each visit, subjects will be asked to complete at least one quality of life questionnaire, undergo a physical assessment (vitals only), blood test to check blood cell levels, and follow-up tumor imaging. Throughout the duration of the study, subjects will be evaluated for complications or side effects that may be related to the procedure and/or Instylla HES device. This study will be conducted at up to 20 sites in the U.S. with additional sites outside of the U.S. It is anticipated that the full investigation will take approximately 2 years.
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.
In this study, we will collect congenital vascular malformation (CVM) tissue samples to examine the vascular and neurological phenotypes in the lesions. We will develop a repository of the remaining CVM samples for our future research which will substantially decrease the need for specimen collections from future CVM subjects. We will also collect blood samples and characterize proteins and RNAs profiles from serum exosomes and metabolites from CVM patients, which will help us to understand the progressive mechanism of CVM.
The purpose of the study is to generate a bio bank of specimens for research. We will tissue that would otherwise be discarded from clinical or surgical procedure and information from medical records. We will also collect discarded blood, urines and sputum. Collecting samples will help to better understanding the mechanisms of cardiovascular diseases, identify biomarkers for early diagnosis and to predict safety and efficacy of new therapies.
The purpose of this study is to evaluate the use of a non-contrast MRI for the assessment of the vasculature of the lower extremity anatomical regions. Patients eligible for this study must have been referred for a clinical contrast enhanced CT scan or an invasive catheter angiography. The overall image quality and diagnostic accuracy of the non-contrast MRI will be compared to current clinical standards of care, such as contrast enhanced MRI, CT, and invasive angiography.
This study is being conduct to assess the safety and effectiveness of a Study Sevice,GORE® EXCLUDER® Conformable AAA Endoprosthesis, in patient's with an aneurysm in their abdominal aorta. In this research study, the Study Device will be placed inside the abdominal aorta (in the approximate area of the belly button) and the Study Device will extend into both leg arteries. The Study Device will block the aneurysm (the weakened and bulging part of the artery) in the abdominal aorta from blood flow while maintaining blood flow to the arteries in the legs. Information will be collected on the performance of the Study Device for up to five (5) years.