A prospective multicenter, open, single design, commercial trial to evaluate the safety and efficacy of NOVUS stent graft in patients with abdominal aortic aneurysm (AAA)

The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 98 人开始时间: 待定最近更新: 2023年8月1日

试验速览

暂无简介。

•1. Common Selection Criteria
•- Adults between the ages of 19 and 90 who understand the purpose of the clinical trial, voluntarily consent, and sign a written consent form
•2. Fusiform aneurysm
•- Abdominal aortic aneurysm more than 5.0 cm in diameter
•- If the diameter increases by more than 0.5cm in 6 months from 4-5cm in diameter or there are related clinical symptoms
•3. Saccular aneurysm at risk of rupture
•4. Pseudoaneurysm or aortic rupture
•5. PAU (more than 2cm in width and more than 1cm in depth)
•- Selection criterion 1 must be satisfied, and only patients with one of the diseases of selection criteria 2, 3, 4, and 5 can be enrolled.

•1. Patients who do not want the procedure
•2. Pregnant women
•3. Diameter of the iliac artery < 5 mm when using a 15 Fr device, < 6 mm when using an 18 Fr device, and < 7 mm when using a 21 Fr device

发起方