Clinical Trials

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.

  Learn more here  For Enrollment

  ---

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.

Learn more here  For Enrollment

Active, Completed Enrollment

Prospective, single arm, multi-center trial of the TCAR Procedure using the ENROUTE® Transcarotid NeuroprotectionSystem (NPS) in standard surgical risk patients with carotid artery stenosis - Roadster 3 (PI Rigberg) 

• The study objective is to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System in patients at standard risk for adverse events from carotid endarterectomy

  Learn more here  

  ---

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST 2) (PI MOORE) 

• CREST-2 is designed to compare three different methods of stroke prevention to find the safest and most effective treatment. The stroke prevention methods include intensive medical management alone compared to intensive medical management in combination with a procedure to reopen the carotid artery in your neck (called revascularization) for treatment of plaque buildup. The two procedures available in this trial are carotid endarterectomy and carotid stenting. All study participants will receive intensive medical management to help control their risk factors for stroke.

  Learn more here

  ---

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis- Hemodynamics (CREST-H) (PI Moore) 

• CREST-H addresses the intriguing question of whether cognitive impairment can be reversed by revascularization when cerebral blood flow is low on the side of a high grade carotid stenosis. We will enroll 500 patients from CREST-2, all of whom receive cognitive assessments at baseline and yearly thereafter. We anticipate identifying 100 patients with hemodynamic impairment as measured by an MRI perfusion (PWI) or CT perfusion (CTP) scan. Among those who are found to be hemodynamically impaired and have baseline cognitive impairment, the cognitive batteries at baseline and at 1 year will determine if those with flow failure who are randomized to a revascularization arm in CREST-2 will have better cognitive outcomes than those in the medical-only arm. This treatment difference will be compared to revascularization versus medical therapy alone in those who do not have hemodynamic impairment.

  Learn more here

  ---

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.

  Learn more here

  ---

Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System - EVAS II (PI Rigberg) 

• Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

  Learn more here

  ---

Coming Soon

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.