Researchers at The University of Texas Health Science Center at Houston (UTHealth) have enrolled the first patient in a phase 3, international trial of a minimally invasive device system to repair descending thoracic aortic aneurysms (TAA).
The principal investigator of the United States arm of the clinical trial is Ali Azizzadeh, M.D., professor and chief of the Division of Vascular and Endovascular Surgery in the Department of Cardiothoracic and Vascular Surgery.
Azizzadeh performed the first procedure at Memorial Hermann Heart & Vascular Institute-Texas Medical Center using the Medtronic Valiant™ Evo Thoracic Stent Graft System on an 88-year-old patient who is doing well post-repair.
“The Valiant Evo clinical study has the potential to expand the applicability of thoracic endovascular aortic repair to a wider spectrum of patients,” Azizzadeh said.
Approximately six out of 100,000 people in the world experience a TAA, a blood-filled bulge or ballooning of the aorta that runs through the chest and can lead to a life-threatening rupture and hemorrhage if not treated. Most people with TAA do not have any symptoms; however, risk factors include smoking, obesity, heredity, injury, or other disease.
The multicenter prospective study will include 100 patients in the United States and Europe. The announcement of the first patient treated was reported today at the 2016 Vascular Annual Meeting of the Society for Vascular Surgery in National Harbor, Md. In the United States, the Valiant Evo is an investigational device and not yet approved for commercial use.