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Research patients know the study or trial they
participate in today could benefit their son, daughter, grandchild or friend in the future. “My disease is hereditary.
I am helping future generations by being a study volunteer”, says Rev. Cozy Gage, a past volunteer. “Participating is
confidential, but I speak out so that others will know I am grateful to have the chance to help others.” Volunteers
also appreciate that being a volunteer is something they can do, instead of something they cannot do.
To volunteer in a research study or trial, a person needs to be willing to remain current with medical appointments
and tests, such as annual cancer screenings and healthy visits with their primary physician. The volunteer will be asked
to provide information about their medical history and surgical history. Every trial volunteer’s information is confidential
and is treated in that way. “Research patients are the best patients, make no mistake!” says Wendy Freiberger, Director of
Clinical Research at Vascular Specialty Center.
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.
Currently enrolling in PRT-201, a multicenter, double-blind, randomized, placebo-controlled, dose escalation study
of a single dose of PRT-201 administered immediately after AVG creation in patients with ESRD. This is a phase II
enrolling on a competitive basis. PRT-202 is a protease, which when applied to the outflow vein, will permanently
dilate the vessel with the goal of longer graft life.
Selected Previous Clinical Trials
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). The initial trial studied
the efficacy and safety of carotid stenting versus conventional surgery in low risk individuals over several years.
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. Surgeons Olinde and Sam have participated in the trial
from the very beginning and are pleased to see the results of this long-term trial begin to influence the treatment
of patients with carotid occlusive disease.
Abdominal Aortic Aneurysm (AAA) Trial sponsored by Medtronix and the Cleveland Clinic Foundation, PIVOTAL- Positive
Impact of EndoVascular Options for Treating Aneurysms Early. Dr. Andrew J. Olinde, Principal Investigator in this
trial is “confident the information gained from this trial impacted the future of surgical treatment in this
population of patients with abdominal aortic aneurysm.” 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.
Our physicians work with those facing the challenges of improving the functionality of the arterio-venous access
graft in Hemodialysis patients. Dr. Albert Sam was selected as a primary investigator to participate in a study
utilizing a novel gene therapy. Sponsored by Ark Therapeutics Ltd, this study of Trinam® was the first clinical
trial of its kind in this area, bringing the future of medicine home to our patients in South Louisiana.
We were 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 may be proven to reduce the risk of stroke associated with carotid surgery. Using
special monitoring devices, the surgeons detected 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 clinical research division was an active participant in recent trials to bring an advanced hemostatic agent
to the market (drug that helps stop bleeding). This drug is used on access and bypass graft surgery patients.
Sponsored by Baxter, we participated in 2 phases of trials to assess the safety and effectiveness of this drug
and have been ranked #1 in enrollment numbers for each phase.
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.
Wendy S. Freiberger, RN, BSN, BA, CCRC, CRCP
Director of Clinical Research
Vascular Specialty Center
wfreiberger@brvsc.com
8888 Summa Ave, Suite B, Baton Rouge, Louisiana, 70809
ph 225-706-0213
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