Clinical Trials

The Department has one of the world’s largest aortic surgery practices and as such is a major center for device development research.  There are a number of ongoing clinical trials at various stages of recruitment, enrollment, and completion.

Active Clinical Trials

  • A randomized controlled comparative study on effectiveness of endovascular repair versus best medical therapy for acute uncomplicated Type B aortic dissection. (ACUTE-B)
    PI: Charlton-Ouw
    Synopsis: Randomized Controlled Trial for patients who present with Acute Uncomplicated Type B Aortic Dissection. Single Center Trial.
  • ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection
    PI: Estrera
    Synopsis: Endovascular treatment of patients with DeBakey Type A Aortic Dissection with Gore Ascending Stent Graft, Feasibility Sponsored Trial.
  • BEST-CLI (Randomized, Multicenter, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia)
    PI: Charlton-Ouw
    Status: Active & Enrolling
    Synopsis: This National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) sponsored study is designed to evaluate the effectiveness of best endovascular (EVT) compared to best surgical (OPEN) revascularization in patients with CLI
  • Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
    PI: Charlton-Ouw
    Synopsis: Endovascular treatment for patients who require coverage of aortic branch vessels to treat aortic dissection, aortic aneurysms, or Traumatic Aortic Injuries. Multi-center sponsored clinical trial.
  • GREAT (Global Registry for Endovascular Aortic Treatment Outcomes Evaluation)
    PI: Charlton-Ouw
    Synopsis: A registry to capture data on individuals with endovascular grafts.  Multi-center sponsored clinical trial.
  • LEOPARD: Multicenter, Observational, Post-Market, Real-World Study to Assess Outcomes of Patients Treated with the AFX® System Compared to other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair LEOPARD: Looking at EVAR Outcomes by Primary Analysis of Randomized Data.
    PI: Harlin
    Status: Active, Not Enrolling
    Synopsis: The objective of this post-market multicenter randomized observational study is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation.
  • Lymphatic Contribution to Progressive Peripheral Vascular Disease and Ulceration 
    Co-PI: Harlin
    Status: Active & Enrolling
    Synopsis: Synopsis: To determine the association if any between early stage lower extremity venous reflux or peripheral arterial disease with lymphatic disease.
  • ON-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
    PI Nguyen
    Synopsis: A registry to examine the performance of the On-X aortic valve using warfarin.  Multi-center sponsored clinical trial.
  • VIEW-VLU: Observational Study of the Effect of Varithena on Wound Healing in the Treatment of Venous Leg Ulcers Resulting from Chronic Venous Insufficiency.
    PI: Harlin
    Status: Active & Enrolling
    Synopsis:  Registry analyzing changes in chronic venous ulcers and quality of life after treatment of veins with Varithena (Polidocanol 1%) foam.
  • Thoraflex Hybrid IDE
    PI: Estrera
    Synopsis: A prospective study assessing the safety and clinical outcomes of the Thoraflex Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta.
  • SAFE (Strategy for Active Follow-up Evaluation)
    PIs: Estrera/Charlton-Ouw
    Synopsis: A prospective study to track outcomes and surveillance of patients after arterial reconstructions
  • TAVR (Trans-aortic aortic valve replacement)
    PIs: Estrera/Smalling
    Synopsis: This study randomizes patients to either percutaneous aortic valve replacement or standard open surgical repair

    Recently Completed Clinical Trials

    (Last Updated: March, 2019)