VIVA 2011: Preliminary Results from the OVATION AAA Stent Graft Study

October 19, 2011—Principal Investigator Manish Mehta, MD, presented preliminary results from the OVATION study during a late-breaking clinical trial session at the VIVA 2011: Vascular Interventional Advances meeting in Las Vegas, Nevada. OVATION is evaluating the preliminary safety and effectiveness of the Ovation abdominal stent graft system (TriVascular, Inc., Santa Rosa, CA) for endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA). The study is being conducted under an investigational device exemption (IDE) approved by the US Food and Drug Administration (FDA).

The 14-F (outer diameter) TriVascular Ovation abdominal stent graft system has a trimodular design, consisting of an aortic body and two iliac limbs. The device separates fixation and seal, with fixation achieved through suprarenal stent anchors and seal achieved through inflatable sealing rings, enabling a low profile.

“The Ovation stent graft allows EVAR to enter the fourth dimension,” commented Dr. Mehta to Endovascular Today. “This truly innovative 14-F (outer diameter) stent graft system represents a novel approach to EVAR, which utilizes infusion of a polymer fill within the main body of the stent graft that cures during the procedure. This allows the stent graft to mold to the aortic neck of variable shapes and sizes to secure a seal and allows for treatment of AAA with complex aortic necks that might not be treatable with currently available devices.”

According to Dr. Mehta, the prospective, multicenter, global OVATION study evaluated the performance of the Ovation stent graft in 161 patients with AAA. Device-related events were evaluated with four-view x-ray and contrast-enhanced computed tomography, and data were available for all patients through hospital discharge and 161 patients through 30 days. Study enrollment is complete, and patient follow-up will continue through 5 years.

Dr. Mehta reported that the OVATION study enrolled 161 patients (male, 87.6%; mean age, 73 ± 8; mean AAA diameter, 55 ± 9 mm) who underwent EVAR with the Ovation stent graft between November 2009 and May 2011. Technical success was achieved in 100% of the procedures. The mean procedure time was 110 minutes, and median hospital stay was 1 day. None of the patients required conversions to surgical repair. There were no type I, III, or IV endoleaks, and no cases of aneurysm rupture or migration were observed. There were no cases of aneurysm enlargement at 365 days. For the primary endpoint, the major adverse event rate at 30 days was 2.5%. The mortality rate at 365 days was 1.9%.

“I'm excited to be able to present this compelling data at VIVA 2011,” concluded Dr. Mehta. “The preliminary results of this FDA-IDE study with the Ovation stent graft are very promising and indicate its safety in treating a wide range of patients, including those with more challenging anatomies. At 14-F outer diameter, a distinct advantage of the Ovation device is its low profile, which, in combination with its innovative sealing technology, allows treatment of AAA that might otherwise be unsuitable for EVAR with currently available stent grafts.”