Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta

Date Added
April 11th, 2024
PRO Number
Pro00135230
Researcher
Sanford Zeigler

List of Studies


Keywords
Cardiovascular, Surgery, Vascular
Summary

Assess the safety and effectiveness of the ASG device in
the treatment of lesions involving the ascending aorta and
aortic arch.

Institution
MUSC
Recruitment Contact
Natalie Koren
843-792-0109
korenn@musc.edu

Protection against Emboli during caRotid artery stenting using a Neuroguard IEP® Direct 3-in-1 delivery system comprised oF a pOstdilation balloon, integRated eMbolic filter, and A Novel Carotid stEnt III

Date Added
February 26th, 2024
PRO Number
Pro00132178
Researcher
Mathew Wooster

List of Studies


Keywords
Vascular
Summary

To evaluate the safety and effectiveness of direct carotid access for stenting using
the Neuroguard IEP® Direct System in subjects at elevated risk for adverse events
following carotid endarterectomy (CEA).

Institution
MUSC
Recruitment Contact
Hannah Culpepper
8437927244
culpepph@musc.edu

Targeting Biomechanical Signaling in AAA

Date Added
January 17th, 2024
PRO Number
Pro00132068
Researcher
Jean Ruddy

List of Studies


Keywords
Vascular
Summary

Patients with large abdominal aortic aneurysms (AAA) (>5.5cm) are recommended to have surgery, but there is no therapy for small AAA (3-5cm). The purpose of this study is to collect ultrasound images and blood from patients with normal abdominal aorta as well as from patients with small AAA. Study participants include patients scheduled for an aortc ultrasound aorta and may fall into one of these categories. By analyzing the aortic wall ultrasound images and the blood levels of particular proteins, we hope to identify a target for drug therapy to stop AAA growth. Voluntary participation in this study does not change the original intent of the ultrasound and does not change patient treatment. The pictures gathered here are in addition to the standard ultrasound and cause no additional risk. Participation would include the standard aorta ultrasound, specific extra pictures (less than 5 minutes to collect), and collection of a blood sample. If a participant's aorta is within normal limits, no additional ultrasound visits or study visits will be indicated. If the participant has a small AAA, standard of care would be to return once per year for repeat ultrasound. Ongoing participation in the study will be to have the extra ultrasound images captured and repeat blood sampling, for a total of 3 years.

Institution
MUSC
Recruitment Contact
Jean Ruddy
843-876-8568
ruddy@musc.edu

Product Surveillance Registry (PSR) Aortic, Peripheral, and Venous (APV) Protocol Synopsis

Date Added
October 24th, 2023
PRO Number
Pro00126447
Researcher
Mathew Wooster

List of Studies


Keywords
Vascular
Summary

The purpose of this registry is to collect safety data in patients undergoing aortic aneurysm repair, peripheral vascular intervention, hemodialysis access intervention or peripheral embolization with an eligible Medtronic market-released product(s), including but not limited to balloon catheters, peripheral or carotid stents, stet grafts, and coils, in a real-world setting.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
8437928896
overstrm@musc.edu

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 Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
1-803-255-2927
sheriods@musc.edu

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

POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in STANDARD RISK PATIENTS with SIGNIFICANT CAROTID ARTERY DISEASE (The ROADSTER 3 Study)

Date Added
January 12th, 2023
PRO Number
Pro00125673
Researcher
Antwana Wright

List of Studies

Keywords
Vascular
Summary

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).

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

ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE

Date Added
December 8th, 2022
PRO Number
Pro00121704
Researcher
Sanford Zeigler

List of Studies


Keywords
Surgery, Vascular
Summary

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.

Institution
MUSC
Recruitment Contact
ShaVon Capers
843-792-7244
caperssh@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



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