We have placed a renewed emphasis on our academic tradition at Ohio State. Faculty in our Division have interests in clinical outcomes research, health care policy/administration/financing, basic and translational stroke mechanisms, and stem cell therapy for limb ischemia. Our research coordinator maintains a prospective database of all procedures for use in retrospective reviews and outcomes studies.
Cameron Rink, PhD, has expanded our scientific focus to include the basic mechanisms of stroke infarct evolution and exciting translational applications of oxygen and nutrient therapy to treat stroke. Dr. Rink’s laboratory is interested in understanding the specific role of molecular oxygen in stroke pathology. Fundamental to this pursuit is the mechanistic understanding of how oxygen serves brain tissue as both a substrate for life-sustaining glucose metabolism, and in a setting of cerebral ischemia as a catalyst for pathological oxidative stress. In pursuing this objective, we have established several novel in vitro and in vivo models to study hypoxic-ischemic cell death, reperfusion injury biology, and by correcting the hypoxia component of stroke, the unique contribution of oxygen to ischemic brain injury. Research efforts span basic to translational science, with an emphasis on cutting-edge scientific tools such as electron paramagnetic resonance imaging for non-invasive oxymetry, and laser capture microdissection for cell and site specific resolution of stroke biology.
Jean Starr, M.D. has a research interest in endovascular surgery and clinical outcomes studies, in addition to serving as the local Principal Investigator, several multicenter trials and registries. Her current projects include a study of the financial impact of ultrasound-accelerated thrombolysis versus standard thrombolysis, long term complications from IVC Filters, and the effect of obesity on surgical site infections. She also leads local and regional advocacy efforts for women in surgery.
Bhagwan Satiani, MD, MBA, has written and presented extensively in the areas of the business of medicine, workforce issues, health care policy, and administration and has become an acknowledged regional and national expert. His recent and current scholarship has focused on workforce shortages. In addition, he is the Director of our ICAVL-accredited vascular laboratory, Course Director of our Annual Vascular Noninvasive Testing Symposium, and is currently establishing a core research vascular lab with expertise in carotid intima-media thickness measurement and brachial artery reactivity testing.
Michael Go, MD, is currently leading a Phase I trial testing the safety and efficacy of bone marrow-derived stem cells for the treatment of critical limb ischemia. He participates as a Co-Investigator in an NHLBI-funded project investigating ethnic heterogeneity in atherosclerosis, where his role is to study differences in carotid intima-media thickness. He also has an interest in clinical outcomes research. Vascular endothelial cell dysfunction associated with PVD may play a role in the clinical manifestations of the disease. Nitric oxide is known to favorably modulate endothelial cell function but bioavailability is a concern. Oral sodium nitrite may be an alternative source of NO that may favorably modulate endothelial cell activity in patients with PAD and affect the clinical manifestations of the disease. This trial is a randomized phase II study assessing the safety, pharmacokinetics, and clinical and experimental endpoints associated with oral sodium nitrite treatment for PAD.
Led by Drs. Starr and Patrick Vaccaro, MD, we have consistently enrolled high numbers of patients in multicenter post-marketing registries and Phase II and III trials. Currently, we are actively enrolling or completing follow-up in the following trials:
Mounir Haurani, MD has research interest in thoracic, abdominal and peripheral aneurysms, carotid disease, venous obstructive disease, peripheral vascular disease, complex endovascular revascularization, IVC filter retrieval and placement, clinical outcomes reactive oxygen species and neointimal hyperplasia.
Maria Litzendorf, MD has research interests in peripheral vascular disease and venous diseases.
Abbott Vascular: CHOICE Post-market registry
Jean Starr, M.D., Principal Investigator. Carotid stenting for high surgical risk patients: Evaluating outcomes through collection of clinical evidence. Primary objectives: to provide additional information that the commercially available Abbott vascular carotid stent systems and embolic protection systems can be used successfully by a wide range of physicians under commercial use conditions. To provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services coverage to a broader group of patients. Closes to enrollment March 2012
Abbott Vascular: HERCULES
Jean Starr, M.D., Principal Investigator. The RX Herculink Elite Renal Stent. Primary objective: To evaluate the safety and effectiveness of the RX Herculink Elite Renal stent system in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of the atherosclerotic de novo or restenotic renal artery stenoses in patients with uncontrolled hypertension. Primary objective: to compare the nine- month binary restenosis rate as determined by duplex ultrasound or angiogram. Closed to enrollment
Arteriocyte, Inc.: CLI trial
Michael Go, M.D. Principal Investigator. Phase I, Non-Randomized, Feasibility Study for the use of bone marrow cell concentrate prepared using Magellan system for the treatment of critical limb ischemia. Primary objective: measure time to treat failure (treatment failure is defined as major amputation of treated limb or death). Open to enrollment
Bolton Medical, Inc.: Relay
Patrick Vaccaro, M.D., Principal Investigator. A phase II clinical study of the safety and efficacy of the Relay Thoracic Stent Graft in Patients with Thoracic Aortic Pathologies. Primary objectives: efficacy and safety. Primary efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay stent graft) through one year. Primary safety will be evaluated by comparing major adverse events within one year in subjects treated using the Relay stent graft with those who underwent open surgical repair. Surgical arm closed. Endovascular arm still open to enrollment
Boston Scientific: ORION
Jean Starr, M.D. Principal Investigator. A Boston Scientific trial of the EPIC Nitinol stent system in the treatment of atherosclerotic lesions in the iliac arteries. Primary objective: to determine whether the Epic Nitinol stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months. Closed to enrollment
Boston Scientific: SuperNOVA
Jean Starr, M.D. Principal Investigator. Stenting of the Superficial femoral and proximal popliteal arteries with the Boston Scientific INNOVA self-expanding bare metal stent system. Primary objective: to determine whether the Nitinol stent shows acceptable performance in long-term (12 month) safety rates and vessel patency when treating femoropopliteal lesions. Open to enrollment
Cook: Zenith TX2 study
Patrick Vaccaro, M.D., Principal Investigator. Zenith TX2 thoracic TAA endovascular graft clinical study. Primary objective: to evaluate the safety and effectiveness of the TX2 thoracic TAA endovascular graft in elective treatment of patients with descending thoracic aortic aneurysms. Closed to enrollment
Cook: Zenith TX2 Low Profile study
Jean Starr, M.D., Principal Investigator. Clinical investigation plan for the Zenith TX2 Low Profile TAA endovascular graft. Primary objective: to evaluate the safety and effectiveness of the TAA graft. The primary safety endpoint will be the major adverse event rate at 30-day follow-up, and the primary effectiveness endpoint will be device success at 12 months. Open to enrollment
Cordis: SAPPHIRE WW post-market registry
Jean Starr, M.D.,Principal Investigator. Stenting and Angioplasty with protection in patients at high risk for endarterectomy. Primary objective: to estimate 30-day MAE rate of stenting distal protection in the treatment of obstructive carotid artery disease in high-surgical risk patients with atherosclerotic disease of the carotid arteries. Enrollment open
CVRX: RHEOS HOPE4HF
Jean Starr, M.D., Principal Investigator. Health outcomes prospective evaluation for heart failure with left ventricular ejection fraction = 40% using the Rheos System. Primary objective: to gather clinical data on the efficacy and safety of the Rheos system compared to current standard of care in patients with symptomatic heart failure and a preserved ejection fraction. Study is ongoing, but not recruiting participants.
Jean Starr, M.D., Principal Investigator. CVRx Rheos pivotal trial. Primary objective: To demonstrate the efficacy and safety of the Rheos system in subjects with stage II hypertension that is resistant to treatment with at least three hypertensive agents, one of which is a diuretic. This trial is being conducted as a pivotal trial for supporting the pre-market approval application to the FDA. Enrollment closed.
Pathway Medical: Jetstream NAVITUS post-market Registry
Jean Starr, M.D., Principal Investigator. A rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. Primary objective: to observe the treatment effects of the Jetstream NAVITUS system in long, occluded, diffuse, thrombotic or calcified lesions in peripheral arterial disease of the common femoral, superficial femoral, or popliteal arteries. To assess and quantify vessel patency 1 year post athrectomy treatment. Open to enrollment