Clinical Trials
Currently Enrolling
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
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.
Coming Soon
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.
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.
Active, Completed Enrollment
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.
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.
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.
Zenith p-Branch Pivotal Study (PI Farley)
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
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.