Post-market European & Asian Registry to Evaluate the Minos™ Stent-Graft and Delivery System in Abdominal Aortic Aneurysm Treatment

A Prospective Multi-centre Observational Real-world Post-market European & Asian Registry With Low-profile Minos™ Abdominal Aortic Stent Graft

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subjects in whom use of the Minos™ Abdominal Aortic Stent-Graft and Delivery System is contraindicated, as follows:
• 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.
• Those who are allergic to contrast agents or unable to tolerate contrast agents due to renal insufficiency.
• Patients with severe coagulation disorder and/or high risk of postoperative hemorrhage.
• Aneurysmal neck angulation greater than 60°.
• Patients with blood supply to vital organs originating from the aneurysmal sac.
• Patients with other comorbidities and whose life expectancy does not exceed one year.
• Subjects with connective tissue diseases, such as Marfan syndrome.
• Minors and pregnant women.
• Subjects who are allergic to nitinol.
• Subjects who are considered not suitable for treatment with stent graft.