Maturation of Arteriovenous Fistula with Automated Sonography Assessments (MAFASA) Trial

Date Added
August 13th, 2026
PRO Number
Pro00149409
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

The purpose of this research is to evaluate the safety and effectiveness of the EchoMark/EchoSure System for AVF (arteriovenous fistula) for assessing AV fistula maturation when used under a protocol of biweekly use as compared to the standard of care follow-up. Target subject population are subjects presenting with Stage 5 Chronic Kidney Disease (CKD5) or End Stage Renal Disease (ESRD) undergoing upper arm autologous arteriovenous fistula creation for hemodialysis access who are on dialysis or will imminently require dialysis (GFR <10).

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

HMBeacon: A Phase 2, Randomized, Double-blind Study of the Safety, Tolerability, Efficacy, and Pharmacodynamics of Multiple Dose ALN-6400 in Adult and Adolescent Female Patients with Von Willebrand Disease (VWD) and Heavy Menstrual Bleeding (HMB)"

Date Added
July 21st, 2026
PRO Number
Pro00151032
Researcher
Shayla Bergmann

List of Studies


Keywords
Obstetrics and Gynecology, Vascular, Women's Health
Summary

This is a study to test the safety of ALN-6400 which is considered to be "an investigational drug", meaning it is not currently approved by regulatory authorities, including the United States Food and Drug Administration (FDA), for the treatment of any disease and find out what effects, if any, it has on people with Von Willebrand Disease (VWD) and Heavy Menstrual Bleeding (HMB). ALN-6400 works by lowering protein in the blood breakdown blood clots and reduce bleeding in women ages 16-45. This study is a 24 week study with an optional extension period of 84 weeks.

Institution
MUSC
Recruitment Contact
Lexi Schorg
8437920603
schorg@musc.edu

Customized Repair for Extensive Aortic pathology using Thoracoabdominal Endografts (CREATE)

Date Added
June 16th, 2026
PRO Number
Pro00149865
Researcher
Ryan King

List of Studies

Keywords
Surgery, Vascular
Summary

The purpose of this research study is to evaluate the safety and effectiveness of a
physician-modified endograft (tubular medical device used to reinforce weakened or damaged blood vessels) for repairing serious diseases of the aorta (largest artery in the human body, responsible for blood from the heart to the rest of the body). This device is considered investigational, and this research study received an Investigational Device Exemption (IDE) from the FDA.

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

Prospective, non-randomized staged pivotal clinical study to assess the safety and performance of the Xeltis Hemodialysis Access graft: Xeltis aXess US Pivotal Study

Date Added
March 4th, 2026
PRO Number
Pro00148886
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

To evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end stage renal disease (ESRD) and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min.

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

POINT FORCE Registry POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter

Date Added
January 8th, 2026
PRO Number
Pro00148793
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

To evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae (access sites used for dialysis) in a real-world scenario.

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

Prospective, multicenter, observational study to evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit (WRAP North America)

Date Added
December 5th, 2025
PRO Number
Pro00147881
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

To evaluate the performance of the Merit Medical WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY device). The WRAPSODY device is used to treat a blocked or narrowed vein you have in your dialysis access circuit that affects your blood flow during dialysis (treatment that removes waste and excess fluid from your blood).

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

Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease

Date Added
April 1st, 2025
PRO Number
Pro00137869
Researcher
Adam Tanious

List of Studies

Keywords
Vascular
Summary

The purpose of this research is to evaluate the efficacy of a new investigational Sirolimus coated balloon device in the treatment of insufficient blood flow of legs (peripheral arterial disease, PAD).

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

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Date Added
February 25th, 2025
PRO Number
Pro00140492
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

This is a prospective, multi-center, double-arm, randomized, single-blind, evaluator blinded clinical trial designed to assess the safety and efficacy of the SelfWrap for prophylactic treatment intended to improve clinical outcomes for CKD patients referred for vascular access creation surgery.

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

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

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



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