The Minos™ Abdominal Aortic Stent-Graft and Delivery System is a medical device designed to treat abdominal aortic aneurysms using a minimally invasive procedure. The device is placed inside the aorta through blood vessels, usually accessed through small incisions in the groin. The goal of this observational study is to collect short-, medium- to long-term safety and performance data of the Minos™ stent-graft in everyday medical practice (real-world settings). The aim is to study about 200 patients worldwide and at least 30 patients in European hospitals.
Diagnosis of infrarenal abdominal aortic aneurysm
Plan to treat with Minos Abdominal Aortic Stent-Graft and Delivery System
Voluntary participation and completion of Informed Consent Form, with willingness to participate in follow-up to 5 years post-procedure
Severe stenosis or calcification near the aneurysm, leading to difficulty in achieving apposition of vessel wall and stent graft.
Difficult access due to severe stenosis or tortuosity in the iliac artery or femoral artery.
Subjects with ruptured aneurysm or acute aneurysm.
Subjects with an infectious aneurysm.
Chinese and European subjects suffering abdominal aortic aneurysm with a proximal neck length ≥15mm.
Cohort
Prospective
Implantation with Minos Stent graft
DeviceTreatment of subjects diagnosed with abdominal aortic aneurysm using the low-profile Minos Abdominal Aortic Stent-Graft and Delivery System. Follow up as per institutional standard of care.
Technical success rate at 12 months
Technical success at 12 months is defined as accurate positioning of stent graft, normal stent shape, no distortion, bending, stenosis and occlusion, and no accidental coverage of internal iliac artery or visceral artery, the absence of aneurysm rupture, continuous type I and III endoleaks after operation, aneurysm enlargement (aneurysm diameter increased by more than 5mm), secondary intervention due to endoleak, stent occlusion or migration, including open surgery and endovascular surgery. Expected secondary interventions will not be included in the analysis.
Incidence of major adverse events at 30 days
Immediate technical success
Immediate technical success is measured as successful introduction and withdrawal of stent graft and delivery system, with accurate positioning of stent graft, normal stent shape, no distortion, bending, stenosis and occlusion, and no accidental coverage of internal iliac artery or visceral artery.
Incidence of successful aneurysm treatment at 2-5 years
Successful aneurysm treatment during the follow-up period of 2-5 years is defined as accurate positioning of stent graft, normal stent shape, no distortion, bending, stenosis and occlusion, and no accidental coverage of internal iliac artery or visceral artery, the absence of aneurysm rupture, continuous type I and III endoleaks after operation, aneurysm enlargement (aneurysm diameter increased by more than 5mm), secondary intervention due to endoleak, stent occlusion or migration, including open surgery and endovascular surgery.
All-cause mortality up to 5 years post-procedure
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