The VIVID clinical trial is studying an investigational device called the Vesper DUO Venous Stent System that includes both the DUO-HYBRID™ and DUO-EXTEND™ stents. These new venous stents are designed to endure the unique forces and motion that happen in deep veins and may reduce the symptoms associated with CVI. They are being studied to treat iliac and common femoral vein blockages with or without a history of a blood clot in the legs.
VIVID is a prospective, multi-center, single-arm, clinical trial investigating the safety and efficacy of the Vesper DUO Venous Stent System in the treatment of iliofemoral occlusive disease.
160 patients will be enrolled at up to 45 U.S. and international clinical sites.
This study is being led by principal investigator Dr. Mahmood Razavi and is currently recruiting adult patients with CVI in the United States and Europe.
If you are at least 18 years of age, your doctor will discuss the study with you in more detail and decide if you meet the criteria to participate in the VIVID Trial. By participating in this trial, you will receive at least 3 years of medical care related to your venous disease following the implant of your venous stent. If you do not qualify, your doctor will discuss other treatment options that are best for you. You will still continue to be followed by your doctor and be treated according to the standard of care at your treatment facility.
The Center for Vein Care is led by Antonios P. Gasparis, MD. A board-certified vascular surgeon, Dr. Gasparis has been in practice for over 10 years. He is a leader in the field of venuous disease, recognized for his work as a clinician, researcher and educator. He is the founder and director of the Center for Vein Care since its inception in 2007.
Dr. Gasparis serves as a Professor in the Department of Surgery at Stony Brook Medicine, where he directs and teaches courses for medical students, surgery residents and vascular surgery residents. He also holds numerous hospital leadership positions including:
Dr. Elias is the Director of the Center for Vein Disease at Englewood Hospital. He is board certified in venous and lymphatic medicine and in general surgery and completed a fellowship in vascular surgery at Englewood Hospital. Educating new and current practitioners is the cornerstone of Dr. Elias’s commitment to modern vein care and its impact on patient outcomes.
He is the founder of the American Venous Forum Fellows Course in Vein Disease, as well as the founder and course director of the annual Expert Venous Management Summit. He is co-founder of Venous Edge, an online video magazine and the medical editor of the American Venous Forum’s newsletter, Vein Specialist. Dr. Elias’s clinical interests include all aspects of minimally invasive vein care; he is also committed to procedure development and teaching.
He has lectured, written, and taught about vein disease both nationally and internationally. He has been principal investigator/investigator on numerous clinical trials and performed the first ClariVein procedure on a human. He is on the Board of Directors for both the American Venous Forum and the American Vein and Lymphatic Society.
His societal memberships include the American Venous Forum, the Society for Vascular Surgery, the International Society of Vascular Surgery, the American College of Phlebology, and the American College of Surgery. He is a Fellow of the American Board of Venous and Lymphatic Medicine and of the American College of Surgeons. He has been director of the vascular vein programs at the Mount Sinai Vein Center and at Columbia University.
John H. Rundback, MD, is a renowned interventional radiologist in practice since 1993 and is the Managing Partner of Advanced Interventional & Vascular Services LLP as well as a partner in NJ Endovascular & Amputation Prevention. He is board-certified in radiology and holds a Certificate of Added Qualification in Angiography and Interventional Radiology. He has been named as a Top Doctor by Castle Connolly.
Dr. Rundback’s clinical and research interests include peripheral arterial disease with a focus on complex tibiopedal therapies for limb salvage, deep venous interventions, carotid stenting, and endovascular aneurysm repair. He has served as the principal investigator on a number of multi-center trials, presented at more than 200 conferences, and published over 100 peer-reviewed articles.
Dr. Rundback is on the Scientific Advisory Board for multiple Strategic Device Companies and is an advisor and on the editorial board for several medical journals. Dr. Rundback is a past member of the Board of Directors of the Society of Interventional Radiology Foundation, as well as a previous member of the Board of Vascular Interventional Advances (VIVA).