Currently Enrolling

Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers (Mavericks) (PI Rowe) 

  • The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device at 12 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.

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Comparing Surgical and Endovascular Arteriovenous Fistula Creation (PI Woo)

  • This study is a pilot study for an eventually larger scale study to compare the results of endovascular arteriovenous fistula (endoAVF) versus surgical arteriovenous fistula (surgAVF). The study aims to determine what the proportion of patients seeking hemodialysis access could qualify for receiving either an endoAVF, surgAVF, or both. Patients who are screened for hemodialysis access must undergo a duplex ultrasound of the blood vessels in the arm to confirm correct sizing. If participants qualify for both procedures they will be randomized to either endoAVF or surgAVF and will track the clinical and patient-reported outcomes of each procedure. Our pilot study hopes to enroll 90 participants. Those outcomes will inform a larger scale study. If the potential participant chooses to abstain from participation in the randomized trial, preferring to decide the method of AVF creation, we will offer to them a chance to join an endoAVF/surgAVF registry that will track the clinical outcomes of the procedure via medical record monitoring.

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Clinical Outcomes and Predictors of Major Adverse Events in Patients Treated for Juxtarenal, Pararenal and Thoracoabdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts (PI Mendes)

  • The purpose of this study is to gather information on the safety and effectiveness of endovascular treatment of three different types of aortic aneurysms (juxtarenal, pararenal and thoracoabdominal-with or without iliac artery involvement) using a system of multiple stent grafts, including the investigational physician-modified stent graft with a combination of fenestrations and/or branches. These physician-modified grafts are considered investigational, which means they have not been approved by the Food and Drug Administration (FDA) for the use described in this study.  However, the FDA has allowed the use of these devices in this research study. There are many FDA approved devices that can be combined to form a physician modified, patient-specific, research graft.

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Active, Completed Enrollment

A Randomized Controlled Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults with End-Stage Kidney Disease on Hemodialysis - The AV ACCESS Trial (site PI Woo)

  • This study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions.

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Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial (C2LOE) (PI Moore) 

  • The purpose of this Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial (C2LOE - ClinicalTrials.gov Identifier: NCT02089217) study is to study is to assess post-procedural efficacy of carotid endarterectomy and carotid stenting.

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