One-year outcomes following repair of thoracoabdominal aneurysms with the multilayer flow modulator: report from the STRATO trial.

PurposeTo evaluate endovascular repair of type II and III thoracoabdominal aortic aneurysms (TAAA) using the Multilayer Flow Modulator (MFM) in patients with contraindications for open surgery and fenestrated stent-grafts.MethodsIn this prospective, multicenter, nonrandomized trial (EudraCT registration: 2009-013678-42; ClinicalTrials.gov identifier NCT01756911), 23 patients (19 men; mean age 75.8 years) with Crawford type II (43.5%) and III (56.5%) TAAA (mean diameter 6.5 cm) were treated with the MFM between April 2010 and February 2011. The primary efficacy outcome measure was stable aneurysm thrombosis with associated branch vessel patency at 12 months; the primary safety endpoint was 30-day and 12-month all-cause mortality.ResultsThe rate of technical success was 100%. In 20 patients with computed tomography scans at 12 months, the primary efficacy outcome was met in 15 patients. The rate of primary patency of covered branch vessels was 96% (53/55); 1 patient with 2 occluded visceral branches underwe...