A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUSTM Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch: TRIOMPHE

Date Added
February 14th, 2022
PRO Number
Pro00115968
Researcher
Ravi Veeraswamy

List of Studies


Keywords
Heart, Pulmonary Arterial Hypertension (PAH), Vascular
Summary

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.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

Multicenter Phenotype-Genotype Analysis of Vascular Anomalies and Related Syndromes

Date Added
December 24th, 2021
PRO Number
Pro00116848
Researcher
Lara Wine Lee

List of Studies


Keywords
Genetics, Pediatrics, Skin, Vascular
Summary

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.

Institution
MUSC
Recruitment Contact
Chelsea Shope
8437549577
shopec@musc.edu

Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature: The LAVA Study

Date Added
July 13th, 2021
PRO Number
Pro00111982
Researcher
D. Thor Johnson

List of Studies


Keywords
Surgery, Vascular
Summary

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.

Institution
MUSC
Recruitment Contact
Elizabeth Kelley
843-792-2305
kelleyep@musc.edu

Shockwave assisted large bore access (TAVR, TEVAR, EVAR, FEVAR)

Date Added
May 11th, 2021
PRO Number
Pro00109540
Researcher
Mathew Wooster

List of Studies


Keywords
Surgery, Vascular
Summary

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

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS treatment-Below The Knee) Randomized Controlled Trial

Date Added
April 27th, 2021
PRO Number
Pro00098760
Researcher
Thomas Todoran

List of Studies


Keywords
Vascular
Summary

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.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu

Weekly Sirolimus Therapy for the Treatment of Venous and Lymphatic Malformations

Date Added
April 6th, 2021
PRO Number
Pro00106369
Researcher
Chelsea Shope

List of Studies

Keywords
Adolescents, Pediatrics, Skin, Vascular
Summary

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.

Institution
MUSC
Recruitment Contact
Alexandra Ritter
7577776673
ritteral@musc.edu

Randomized Multi-Center, Subject and Evaluator Blinded, Parallel- Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared with Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Arterial Chemoembolization (cTACE) for Vascular Occlusion of Hypervascular Tumors; A Pivotal Study

Date Added
February 23rd, 2021
PRO Number
Pro00106547
Researcher
Marcelo Guimaraes

List of Studies


Keywords
Kidney, Liver, Surgery, Vascular
Summary

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.

Institution
MUSC
Recruitment Contact
Elizabeth Kelley
843-792-2305
kelleyel@musc.edu

Pulmonary Vascular Complications of Liver Disease 3 (PVCLD3)

Date Added
January 22nd, 2021
PRO Number
Pro00103260
Researcher
David Koch

List of Studies


Keywords
Hypertension/ High Blood Pressure, Liver, Men's Health, Pulmonary, Transplant, Vascular
Summary

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.

Institution
MUSC
Recruitment Contact
Christian Conley
(843)876-4273
conleyc@musc.edu

Human Samples Biorepository

Date Added
August 21st, 2018
PRO Number
Pro00072807
Researcher
Federica del Monte

List of Studies


Keywords
Aging, Cardiovascular, Coronary Artery Disease, Genetics, Heart, Military, Sarcoidosis, Scleroderma, Transplant, Vascular
Summary

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.

Institution
MUSC
Recruitment Contact
Federica del Monte
843-792-8397
delmonte@musc.edu

Research Trial for Optimized Nonenhanced 3T QISS MR Angiography of the Peripheral Arteries and Veins

Date Added
August 17th, 2017
PRO Number
Pro00070277
Researcher
Uwe O.P. Schoepf

List of Studies


Keywords
Cardiovascular, Vascular
Summary

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.

Institution
MUSC
Recruitment Contact
Brian Jacobs
843-876-4922
Jacobsbr@musc.edu



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