US-based W L Gore and Associates (Gore) has implanted the first subject in the ARISE II study of its ascending stent graft, for patients who require endovascular treatment of the ascending aorta.
The company’s ascending stent graph, designed for investigational use, is used in conjunction with the Gore TAG thoracic branch endoprosthesis.
ARISE II aims to assess the potential of using the transcatheter endovascular stent graph as an alternative to open surgical repair for the diseased part of the ascending aorta. While endovascular technologies have been successful in other aortic regions to minimise complications and recovery times, Gore highlights that no endovascular device is currently approved by the US Food and Drug Administration (FDA) for the ascending aorta.
Eric Roselli, who serves as the national principal investigator of the trial at Cleveland Clinic, performed the case earlier this month. The patient had a fusiform aneurysm of the ascending aorta and aortic arch.
In the announcement accompanying the development, Roselli said: "The treatment of the ascending aorta has long been a 'final frontier' in endovascular surgery. ARISE II is a significant step forward as we search for minimally invasive options that can be offered to higher-risk patients."
Results from the ARISE early feasibility trial, initiated in 2018, were published in the Journal of Endovascular Therapy last year. Procedures were safely carried out in all 19 patients enrolled in the trial, presenting with a mix of DeBakey type I and II diseases. At 30 days, major adverse cardiovascular and cerebrovascular events (MACCE) occurred in five patients, including mortality, stroke, and myocardial infarction.
In June 2023, Gore initiated a clinical trial comparing its Gore VIABAHN VBX balloon-expandable endoprosthesis (VBX Stent Graft) to bare metal stenting in patients with aortoiliac occlusive disease. The study will enrol 244 patients at up to 40 sites in Australia, New Zealand, Europe, and the US, with one-year results expected in 2027.
A market model on GlobalData’s Medical Intelligence Center estimates the aortic stent graft market was worth $1.4bn in 2020 and is expected to grow to $2.1bn by 2030 in the US.
GlobalData is the parent company of Clinical Trials Arena.
