A Prospective Multi-centre Observational Real-world Post-market European & Asian Registry With Low-profile Minos™ Abdominal Aortic Stent Graft
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Technical success rate at 12 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
PEARL participants
All subjects to be treated with Minos™ Abdominal Aortic Stent-Graft and Delivery System who meet the criteria for inclusion in the PEARL study and voluntarily consent to participate.
干预措施: Implantation with Minos Stent graft (Device)
结局指标
主要结局
Technical success rate at 12 months
时间窗: 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.
次要结局
- Aneurysm diameter and variation in aneurysm diameter from 30 days to 5 years post-procedure(From 30 days post-implantation until end of follow up at 5 years)
- Incidence of type I and type III endoleaks from 30 days to 5 years post-procedure(From 30 days post-implantation until end of follow up at 5 years)
- Incidence rate of stent migration, fracture, stenosis, occlusion and distortion from 30 days to 5 years post-procedure(From 30 days post-implantation until end of follow up at 5 years)
- Incidence of major adverse events at 30 days(30 days)
- Immediate technical success(within 24 hours post-implantation)
- Incidence of successful aneurysm treatment at 2-5 years(Years 2-5 post-implantation)
- All-cause mortality up to 5 years post-procedure(From implantation to the end of follow up at 5 years)
- Aortic aneurysm related mortality up to 5 years post-procedure(From implantation to the end of follow up at 5 years)
- Secondary intervention rates up to 5 years post-procedure(From implantation to the end of follow up at 5 years)