Lombard Medical has announced the enrolment and treatment of the first patient in the ARCHYTAS global registry. An 89-year-old male with a 64mm aneurysm and challenging 75-degree aortic neck angulation was treated with Lombard Medical’s Aorfix endovascular stent graft in Girona, Spain.
“Aorfix was deployed easily with a favourable acute outcome and the patient is doing well,” said Omar Andres Navarro, chief of service, Vascular and Endovascular department at Dr Joseph Trueta University Hospital, who treated the patient. “We look forward to monitoring the long-term results of this case and are excited to enrol additional patients into this important study.”
The ARCHYTAS registry is a global, randomised, single-arm prospective registry designed to quantify the clinical outcomes of endovascular aortic repair with Aorfix in a broad cross-section of patients with abdominal aortic aneurysms. The registry plans to enrol up to 500 patients at 50 sites worldwide and will follow patients for five years. Outcome measures include success at 12 months, freedom from: sac expansion, type I and III endoleaks requiring re-intervention, rupture, conversion to open surgery, graft migration and limb occlusion. The study is led by Vincent Riambau, chief of the Vascular Surgery Division at the Thorax Institute, Hospital Clinic at the University of Barcelona, Spain.
“ARCHYTAS is the first post-market registry to include abdominal aortic aneurysm patients with both straightforward and highly angulated anatomies,” said Simon Hubbert, chief executive officer of Lombard Medical. “We are confident that ARCHYTAS, in conjunction with other ongoing studies, will establish Aorfix as the only stent graft both indicated and clinically demonstrated to treat the most diverse range of abdominal aortic aneurysm patient anatomies.”
