Prospective multicenter study of the low-profile Relay stent-graft in patients with thoracic aortic disease: the RE-GENERATION study

Abstract Purpose To evaluate the early safety and clinical performance of the new low-profile RelayPro Thoracic Stent-Graft System in patients with thoracic aortic disease. Methods This was an international, prospective, single-arm study in patients diagnosed with thoracic aorta disease (aneurysm, pseudoaneurysm, dissection, penetrating aortic ulcer [PAU], or intramural hematoma) and treated with a RelayPro stent-graft (in bare stent and/or non-bare stent configurations). The primary endpoints were freedom from aneurysm or dissection-related mortality and stent-graft performance. Results A total of 31 patients were treated with the RelayPro thoracic stent-graft between 2014 and 2015 at eight sites in Italy and Spain. Mean age was 72.1 (±10.2) years and 77% were male, 74% with hypertension, 42% with a history of smoking. Twenty-four (77%) had aneurysms (fusiform in 46%, saccular in 42%, pseudoaneurysm in 12%); five (16%) had PAU; and two (6%) had chronic Type B dissection. Mean vascular access diameter was 9.1 mm (6–13 mm); seven patients (23%) had vascular access of 7 mm or less. Technical success was 100% (primary, 90%; assisted primary, 10%). Freedom from aneurysm/dissection-related mortality through 30 days was 100%. Freedom from device-related major adverse events through 30 days was 94%. At one year, there was one (3%) type Ib and one (3%) type II endoleak, one (3%) non-aneurysm-related late death, and one (3%) secondary intervention (to correct type Ib endoleak). Conclusion The RelayPro has a 3–4 French profile reduction to allow endovascular repair of thoracic aortic disease in patients with smaller anatomies. This study shows good initial stent-graft performance and a favorable early safety profile.