Vascular Surgery

Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia

Principal Investigator: Kristina Giles, MD

Study Description: This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options. Male and female subjects aged 18 years or older will be randomized to receive either open surgical treatment or endovascular treatment. They will be followed for at least 2 years and up to 4 years and 2 months after treatment to primarily assess survival and major adverse limb events in the index or treated limb, and secondarily, to determine clinical and cost effectiveness outcomes after treatment. These outcomes (survival-free of major limb events and clinical, functional and cost effectiveness) will be compared within two cohorts of subjects: those with an available single-segment great saphenous vein, and those with an alternative conduit. The null hypotheses for both cohorts is that there will be no difference in MALE-free survival between best endovascular therapy and best surgical therapy.


PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation

Principal Investigator: Thomas Huber, MD, PhD

Study Description: The purpose of this extended study is to collect confirmatory safety and effectiveness data on the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in the treatment of aortoiliac and iliac aneurysms.


Evaluation of Valiant Mona LSA

Principal Investigator: Javairiah Fatima, MD

Study Description: The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the identified subject population. This study will also evaluate the current instructions for use and may direct changes to the delivery and deployment steps.

The purpose of the expansion to the Feasibility Study is to characterize the Valiant Mona LSA Thoracic Stent Graft System, in particular to assess the safety and effectiveness of the device acutely and at the 30 day visit, in subjects enrolled with chronic, Type B dissections.


Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection

Principal Investigator: Martin Back, MD

Study Description: This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.

Subjects will be enrolled on a first come, first serve basis; however, no single investigational site may enroll more than 20% of the proposed sample size of up to 80 subjects. A subject is considered enrolled when arterial access is gained and an attempt is made to introduce the RelayPro Thoracic Stent-Graft. Enrollment is expected to begin in mid-2016 and complete by the end of 2020.

All subjects enrolled, as defined above, will be included in the patient population for the primary safety analyses. All subjects implanted with the RelayPro Thoracic Stent-Graft will be included in the patient population for the primary effectiveness analyses.


Relay PRO Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

Principal Investigator: Martin Back, MD

Study Description: The objective of this study is to investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.


Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta

Principal Investigator: Javairiah Fatima, MD

Study Description: The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.


A Randomized Double Blind Placebo Controlled Clinical Study to Assess Blood-Derived Autologous Angiogenic Cell Precursor Therapy in Patients with Critical Limb Ischemia (ACP-CLI)

Principal Investigator: Kristina Giles, MD

Study Description: This study will determine the safety and effectiveness of ACP-CLI intramuscular injections in treating patients with critical limb ischemia, who have no further surgical or endovascular treatment options. ACP-CLI is a stem-cell treatment created using a patient’s own blood cells. Patients in the trial will be randomized to receive either ACP-CLI or a placebo.


PRT-201-115: A PHASE 1 MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-ESCALATION STUDY OF VONAPANITASE ADMINISTERED FOLLOWING ANGIOPLASTY OF A DISTAL POPLITEAL, TIBIAL OR PERONEAL ARTERY IN PATIENTS WITH PERIPHERAL ARTERY DISEASE

Principal Investigator: Kristina Giles, MD

Study Description: This study will assess the feasibility and safety of using Vonapanitase to treat peripheral artery disease in the legs. Vonapanitase will be injected into the affected artery using a microcatherter, immediately following a successful angioplasty. Patients in the study will be randomly assigned to receive treatment with either one of three different dose levels of Vonapanitase, or the placebo.

Please contact Nancy Hanson at 352.273.7598 or nancy.hanson@surgery.ufl.edu for more information about vascular surgery clinical trials.