LIBREXIA - AF A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation

Date Added
August 15th, 2023
PRO Number
Pro00130569
Researcher
James Phillips

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Vascular
Summary

This is a study comparing the new class anticoagulants factor XIa to the FDA approved Apixaban. The study is to determine if Milvexian is as effective and safe with preventing clots for patients with A-fib and to determine if Milvexian is better at reducing the chances of bleeding.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Jacqueline Sheriod-Scott
1-803-255-2927
sheriods@musc.edu

WATCHMAN FLX versus NOAC for EMbolic ProtectION in the management of patients with Non-Valvular Atrial Fibrillation (CHAMPION-AF)

Date Added
April 26th, 2022
PRO Number
Pro00116671
Researcher
Loren Morgan

List of Studies

Keywords
Cardiovascular, Heart, Vascular
Summary

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.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
803-255-2927
sheriods@musc.edu

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 Hypertension, 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

BOLT: A Prospective, Multicenter Study of Patients with Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System

Date Added
January 12th, 2022
PRO Number
Pro00115726
Researcher
Antwana Wright

List of Studies

Keywords
Surgery, Vascular
Summary

The purpose of this study is to observe the safety and effectiveness of the Indigo Aspiration System. This study will help determine how study participants recover when the study device is used to remove the clot from the deep veins.

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

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 Richmond
7577776673
ritteral@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



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