Clinical Trial Considerations in Cerebral Protection for TAVR Patients – An Examination of Study Design, Endpoints and Imaging Methods

Alan B. Lumsden, MD, ChB, RVT, FACS, Medical Director, Medical Metrics

Dr. Alan Lumsden is the medical director for Medical Metrics and a faculty member at Houston Methodist. Dr. Lumsden has developed an international reputation as a leader in the field of endovascular surgery. He has clinical and research expertise in stent graft treatment of thoracic and abdominal aortic aneurysms, stenting and endarterectomy in carotid arterial disease, renovascular hypertension, aortoiliac occlusive disease, mesenteric vascular and minimally invasive therapy in venous disease. Dr. Lumsden also conducts FDA-mandated training for surgeons nationwide in a carotid stenting simulator housed at the Houston Methodist DeBakey Heart and Vascular Center.

Dr. Lumsden’s research interests include developing novel minimally invasive methods of therapy and preventing restenosis. Dr. Lumsden’s academic career began at Emory University in Atlanta, Georgia where he completed his postdoctoral training and served as a Collaborative Scientist in the Division of Pathobiology and Immunology at the Yerkes Primate Center

Zsolt Garami, MD, Director of Vascular Imaging, Medical Metrics

Dr. Zsolt Garami is the director of imaging for Medical Metrics and a faculty member at Houston Methodist. Dr. Garami has a clinical background in radiology and is EU board certified in that specialty. He has also received further specialization in intracranial ultrasound in Europe and the United States. In recent years, Dr. Garami has become a nationally recognized leader in transcranial doppler (TCD) imaging.

Dr. Garami´s research focuses on understanding and treating intracranial flow disturbances that cause stroke. He has numerous publications on the monitoring of the cerebral vasculature during vascular procedures such as coronary artery bypass grafting, and carotid artery surgery. His current studies aim to reveal critical patterns of distal intracranial embolization in LVAD patients.

Richelle Massey, Senior Director, Project Management, Medical Device & Diagnostic Division, Novella Clinical

Richelle Massey provides strategic leadership and program management oversight for Novella Clinical’s Medical Device & Diagnostic Division. Mrs. Massey has more than 11 years of medical device and clinical trial management experience including clinical trial strategy for CLIII type devices, enrollment, execution, vendor management, and regulatory approval. Mrs. Massey has held several leadership positions within Clinical Project Management and Regulatory Affairs at CardioKinetix and Guidant Corporation/Abbott Vascular where she supported programs for drug-eluting stents and bioresorbable scaffolds. Mrs. Massey received her Bachelors in Marketing from Santa Clara University and her M.B.A. from the University of Phoenix.