Newswise — SIOUX FALLS, S.D. – Sanford Health is enrolling patients for a clinical trial using a less-invasive method to treat thoracoabdominal aortic aneurysms. Patrick Kelly, M.D., developed the investigational device and associated surgical procedure.
An aneurysm is an enlargement in the wall of a blood vessel that can lead to tearing and life-threatening bleeding. Kelly’s stent graft system, described in a recently published article in the Journal of Vascular Surgery, seals thoracoabdominal aneurysms, which involve the thoracic aorta and extend into the abdominal aorta. Thoracoabdominal aortic aneurysms often include the branch arteries that supply blood to the liver, spleen, intestine, kidneys and other organs in your abdomen.
The safety profile of the stent graft system will be studied. The study will be performed under a physician-sponsored investigational device exemption, which is a medical device clinical trial approved by the FDA. Patients must meet requirements related to the location, size, history of growth and risk of rupture of their aneurysm. Enrollees must also be older than 18 and have a life expectancy greater than one year.
“This less-invasive method is important for patients who, for various reasons, are not candidates for more invasive methods of treatment and are limited in care options,” said Kelly. “Patients with thoracoabdominal aortic aneurysms who enroll in this trial may be able to help advance the science behind treating aortic disorders.”
The clinical trial, based out of Sioux Falls, is part of Sanford’s Advanced Aortic Program, which provides diagnosis, second opinions and non-invasive treatments for diseases and disorders of the arteries, veins and lymphatic system outside of the heart.
“Dr. Kelly’s device, procedure and clinical trial represent the commitment Sanford Health has to innovative and patient-centered care,” said David Pearce, Ph.D., president of Sanford Research. “Our investments in such projects support discovery and advancements for both physicians and investigators.”
Kelly is medical director of Sanford Vascular Services, Sanford Wound Clinic and the Sanford Advanced Aortic Program in the Sioux Falls region and a board-certified and fellowship-trained vascular and general surgeon. He holds dozens of patents and patent applications for medical devices and has served as a principal investigator for several clinical trials. For information on clinical trial participation, call (605) 312-7300.
About Sanford HealthSanford Health is an integrated health system headquartered in the Dakotas and is now the largest, rural, not-for-profit health care system in the nation with locations in 126 communities in nine states. In addition, Sanford Health is in the process of developing international clinics in Ghana, Mexico and China.
Sanford Health includes 43 hospitals, 140 clinic locations and 1,360 physicians in 81 specialty areas of medicine. With more than 26,000 employees, Sanford Health is the largest employer in North Dakota and South Dakota. The system is experiencing dynamic growth and development in conjunction with nearly $1 billion in gifts from philanthropist Denny Sanford. These gifts are making possible the implementation of several initiatives, including global children's clinics, multiple research centers and finding cures for type 1 diabetes and breast cancer. For more information, visit sanfordhealth.org.
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