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Research
The Division of Vascular and Endovascular Surgery is actively involved in clinical and translational research studies, which are funded by federal and state government, private foundations and the pharmaceutical and biotechnology industries. At UC Irvine, faculty members encourage surgical residents and medical students to participate in these research opportunities and support them during their research tenure. Surgical residents also have an opportunity to spend a year as a research fellow in the division with a faculty mentor.
Current active clinical studies include:
CSP #498: O.V.E.R.
The Veterans Administration Open Versus Endovascular Repair of Abdominal Aortic Aneurysms(AAA) Trial (Veterans Administration Cooperative Studies), is investigating all-cause mortality between endovascular aortic aneurysm repair (EVAR) and open surgery. It is a treatment, randomized, open label, active control, parallel assignment and efficacy study where patients are randomized to one of these repair strategies for the elective treatment of AAA: (a) open surgery or (b) endovascular repair (using FDA-approved devices). Patients for whom elective repair of AAA is indicated and who are suitable candidates for both open repair and EVR will be eligible for the study. The anticipated duration of the study is 9 years with a proposed sample size of 900 patients, involving 44 Federal VA Medical Centers.
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVITOL) Trial,
Patients are being recruited for the PIVITOL Trial, which will investigate whether repair of small aneurysms is superior to surveillance with respect to the frequency of rupture or aneurysm related deaths. It is a Phase IV, interventional treatment, randomized, open label, active control, crossover assignment, safety/efficacy study. The purpose of this study is to compare endovascular repair using the AneuRx stent graft system versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA) (4-5cm), with respect to patient survival, AAA rupture and AAA related deaths. Proposed enrollment is 1050 patients, involving 62 US study locations.
Mixed Antagonist of Serotonin for Claudication Optimal Therapy (MASCOT) Trial
Clinical recruitment has been completed for the MASCOT Trial, an interventional, Phase II treatment, randomized, double-blind, placebo control, parallel assignment, safety/efficacy study investigating patients suffering from intermittent claudication due to Fontaine stage II peripheral arterial disease. It evaluated whether a 24-week treatment by SL650472 OD on top of clopidogrel may result in an improvement of walking capacity by comparing three doses of SL650472 to placebo, and to calibrate such effect versus cilostazol. There were 580 patients enrolled, involving US study locations.
RE-MOBILIZE: A Phase III, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Study
Enrollment has been completed for RE-MOBILIZE, which investigates the efficacy and safety of two different dose regimens (75 mg day 1 followed by 1150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of Dabigatran Etexilate administered orally (capsules), compared to Enoxaparin 30 mg twice a day subcutaneous for 12-15 days in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery. Primary outcome measure was to investigate total venous thromboembolic event (VTE) and all cause mortality during the treatment period, with a secondary endpoint of evaluating major VTE (defined as proximal DVT and PE) and VTE related mortality proximal DVT total DVT symptomatic DVT pulmonary embolism (PE) Death. There were an estimated 500 patients enrolled, involving US study locations.
Safety of Vascugel™ Treatment after Creation of Arteriovenous Access for Hemodialysis Use
This study has been initiated, but currently is not recruiting patients. It is a randomized, double-blind, parallel group, Phase I/II clinical trial of Vascugel™ treatment vs. Gelfoam® in patients undergoing creation of an arteriovenous graft or fistula for hemodialysis access. Vascugel™ consists of allogeneic cell therapy where a biologically-active matrix of endothelial cells is placed directly on traumatized vessels to stimulate natural repair and regeneration while minimizing intimal hyperplasia.
Vascular Outcomes Studies
The Division of Vascular and Endovascular Surgery has established collaboration with the UC Irvine Center for Health Policy Research, investigating vascular outcomes studies. Recently a study utilizing the National Health and Nutritional Survey(NHANES) was assessed to determine specific nutrients associated with prevalent PVD in the US population. Improved nutrition is associated with a reduced prevalence of PVD in the US population. Higher consumption of specific nutrients, including antioxidants (vitamins A and C), fiber and folate have a significant protective effect, irrespective of traditional cardiovascular risk factors. These findings suggest specific dietary supplementation may afford additional protection, above traditional risk factor modification, for the prevention of PVD. Conclusive evidence for dietary supplementation in PVD must come from randomized trial evidence and these data support and encourage larger clinical trials to be performed in the United States. There is ongoing collaboration evaluating additional large national databases to further knowledge by outcomes studies.
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