Medtronic Inc today reported the start of THRIVE, the company’s US post-market clinical study of its Talent thoracic stent graft for the endovascular repair of thoracic aortic aneurysms.
Addressing a condition of US Food and Drug Administration (FDA) approval, THRIVE will enroll a total of 451 patients at a minimum of 15 US sites. The study’s primary endpoint is freedom from aneurysm-related mortality – defined as death from aneurysm rupture or from any procedure intended to treat the segment targeted by the Talent system – at five years.
The study design incorporates the test group of 195 subjects from the earlier study that supported the device’s FDA approval in 2008, as well as an additional 256 new subjects to be prospectively enrolled. All subjects will be followed for five years.
“THRIVE will gather clinically-relevant data on the long-term safety and efficacy of the Talent thoracic stent graft in a real-world, US patient population,” said Karthikeshwar Kasirajan, the principal investigator of THRIVE, and leader of the team that performed the first study implant on 20 April at Emory University Hospital in Atlanta, USA.
“In my experience, the Talent system offers controlled deployment for placement accuracy, and enables more patients to be treated due to its broad range of diameters.”
With more than 10 years of clinical use worldwide, the Talent stent graft has been implanted in more than 20,000 patients. The device was approved by the FDA in June 2008.