Ravi Rajani Named National PI of Trial Evaluating Relay PRO Stent-Graft for Trauma to Descending Thoracic Aorta
APRIL 2017
Ravi Rajani, MD, associate professor of surgery and chief of vascular and endovascular surgery at Grady Memorial Hospital, has been named national principal investigator of a prospective, multicenter, non-blinded, non-randomized study of the RelayPro Thoracic Stent-Graft in subjects with traumatic injury of the descending thoracic aorta. Jaime Benarroch-Gampel, MD, assistant professor of surgery and a member of the vascular surgery team at Grady, will be the Emory PI for the Grady site of the study.
"Traumatic aortic rupture has a very high rate of mortality and morbidity, though over the past 20 years or so various types of stenting and grafting procedures have offered more effective means of repairing aortic tears and transections," says Dr. Rajani, who has been the PI for several trauma-specific clinical trials. "Possible advantages of the RelayPro system are that the delivery mechanism allows for improved positioning, and the stent is designed to adapt to the aortic anatomy without modifying the vessel morphology."
The trial is expected to enroll up to 50 patients nationally who are candidates for endovascular repair. "Considering the volume of blunt thoracic injuries we see at Grady's Level I trauma center and our familiarity with treating these conditions, we will undoubtedly be able to substantially contribute to the national recruitment of patients," says Dr. Benarroch-Gampel.
The trial's primary objective will be to document all-cause mortality at 30 days post procedure, after which it will measure outcomes and any complications through five years of follow-up. During the follow-up, Drs. Rajani and Bennarroch-Gampel will monitor the incidence of any adverse events related to the device, such as endograft infection, leaking, migration from its original placement, fractures in the attachment zone, loss of patency, aortic expansion, and other unwelcome crises.
RelayPro Thoracic Stent-Grafts were originally designed for the management of patients with aneurysms and penetrating ulcers within the descending thoracic aorta. "Those conditions share certain life-threatening qualities with the conditions we will be responding to, which bolsters the hypothesis that if the grafts prove to be effective for their initial purpose, it is likely they will also perform well in trauma situations," says Dr. Rajani.
