Clinical Research

Our clinical research division is active with trials of an advanced hemostatic agent (drug that helps stop bleeding) that is used on access and bypass graft surgery patients.  Sponsored by Baxter,  we have  participated in 2 phases of trials to assess the safety and effectiveness of this drug and have been ranked #1 in enrollment for each phase. 

We are one of 4 sites in the US and also of only 12 sites in the world selected to participate in a trial of a new drug compound that could help reduce the risk of stroke associated with carotid surgery.  Using special monitoring devices, the surgeons will detect the number of microembolic particles present immediately following carotid surgery to investigate effects of the drug.   “Collaboration is essential;” Says Dr. Victor Tran, “We are working every day here  in our research division to find ways to improve the lives of our patients.”

Our physicians also are facing the challenges  of improving the functionality of the arterio-venous access graft in Hemodialysis patients.  Dr Albert Sam has been selected as a primary investigator to participate in a study utilizing a novel gene therapy.   “We believe in reaching for a higher standard”, he stated as he attended specialized training at Duke University.  “We have to improve the reliability of these grafts.”  This study will be enrolling by the end of 2009.  Sponsored by Ark Therapeutics Ltd, this study will assess the efficacy and safety of Trinam® and will assess primary unassisted patency and survival of vascular access grafts in Hemodialysis patients with end stage renal disease.  (The ADVANTAGE Trial)

Vascular Specialty Center is a designated center in Baton Rouge, Louisiana, for the National Institutes of Health (NIH)-sponsored Carotid Revascularization: Endarterectomy vs. Stenting Trial (CREST) Trial.  The trial studies the efficacy and safety of carotid stenting versus conventional surgery in low risk individuals. This is the largest randomized trial in North America comparing the use of these two modalities in preventing stroke, myocardial infarction, and death in the population at risk.

Abdominal Aortic Aneurysm (AAA) Trial sponsored by Medtronix and the Cleveland Clinic Foundation, PIVOTAL- Positive Impact of EndoVascular Options for Treating Aneurysms Early.

Vascular Specialty Center remains one of the only centers in the United States to offer laparoscopic aortic reconstruction. Certified, we have performed these procedures in selected patients with excellent results that have been presented at national and international scientific meetings. Our results have also been published in the Journal of Vascular Surgery, the leading peer-reviewed publication in the field of vascular and endovascular surgery.

Vascular Specialty Center has developed, supports and participates in an area-wide, quality outcomes registry for vascular patients to assure that patient care is optimized. This provides consistent quality assurance and improvement by monitoring the complications and outcomes related to the patient’s vascular procedure. All data is entered in a prospective, ongoing database that links the entire enrolled medical community.

Selected Previous Clinical Trials

Vascular Specialty Center is one of only 40 centers chosen nationwide to participate in a post-marketing trial of the SilverHawk Device, a new device that is FDA-Approved to cut occluding plaque (atherosclerotic lesions) directly off the wall of a diseased artery. Ranked #1 in the US.

As a research site for the “TRELLIS” Device study called STRIDE, the surgeons are discovering promising new therapeutic options for persons in the treatment and removal of new-onset blood clots (DVT). 

Glaxo Smith Kline (GSK ITI 101711) trial for Deep Vein Thrombosis prevention in patients undergoing Total Knee Replacement.

Ranked #1 in the US, Zymogenetics 499E01, a clinical trial that studied the effects of a hemostatic agent (drug that helps stop bleeding) that is used in surgery on the access in dialysis patients.

Ranked #1 in the US and 3rd in the world, Vascular Specialty Center has been a leader in the clinical trial SOV302 (GE HealthCare) which assesses the efficacy and safety of a contrast agent used for Magnetic Resonance Angiography (MRA) of the arteries and compares its image quality to angiography.

Ranked in the top 3 sites for the Expedial Dialysis Access trial sponsored by LeMaitre Vascular.

Ranked #1 in the nation for enrollment, Vascular Specialty Center has been a leading participant for the PREVENT V Multicenter clinical trial, a study testing the effects of treating the venous anastomosis during dialysis access surgery with a drug that can reduce narrowing and graft failure.

Ranked #1 in the nation for enrollment in the C.O.M.P.A.R.E. study which regards the post-market evaluation of a vascular clip (U-clip) device that has been shown to improve the maturity rate of AV Fistulas and durability of certain bypass procedures.

Ranked 6th in the nation for enrollment, Vascular Specialty Center has been a leading participant for the PREVENT III clinical trial; a study testing the effects of treating vein grafts prior to bypass with a drug that reduces narrowing and graft failure.

Vascular Specialty Center participated in the clinical trial DXV303 sponsored by Amersham Health. This study tested the efficacy and safety of a new contrast agent used for angiography. In addition, the study compared the data and outcomes between CT angiography versus conventional angiography.

The Flow Medica FEN 002 trial studied the direct intra-renal (kidney) infusion of Fenoldopam, medicine given to patients who are high risk for radiocontrast nephropathy (kidney failure) undergoing angiography.

We are dedicated to providing the best, most up-to-date care for our patients and thus will remain intimately involved in clinical research.