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

2026年6月23日 更新者：Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
      • Beijing、中国、100037
        • 招聘中
        • Fuwai Hospital
        • 首席研究员：
          • Chang Shu
    • Gansu
      • Lanzhou、Gansu、中国、730030
        • 招聘中
        • The Second Hospital of Lanzhou University
        • 首席研究员：
          • Dong Zhou
    • Guangdong
      • Meizhou、Guangdong、中国、514031
        • 招聘中
        • Meizhou People's Hospital
        • 首席研究员：
          • Cunren Li
      • Shenzhen、Guangdong、中国、518053
        • 招聘中
        • The University of Hong Kong - Shenzhen Hospital
        • 首席研究员：
          • Minxin Wei
    • Hunan
      • Changsha、Hunan、中国、410002
        • 招聘中
        • Hunan Provincial People's Hospital
        • 首席研究员：
          • Qing Wang
      • Xiangtan、Hunan、中国、411100
        • 招聘中
        • Xiangtan Central Hospital
        • 首席研究员：
          • Zhihong Fang
      • Yueyang、Hunan、中国、414000
        • 招聘中
        • Yueyang Central Hospital
        • 首席研究员：
          • Yi You
    • Shandong
      • Zibo、Shandong、中国、255024
        • 招聘中
        • Zibo Central Hospital
        • 首席研究员：
          • Xinming Yu
    • Tianjin Municipality
      • Binhai、Tianjin Municipality、中国、300457
        • 招聘中
        • Teda International Cardiovascular Hospital
        • 首席研究员：
          • Xuedong Li
    • Yunnan
      • Kunming、Yunnan、中国、650051
        • 招聘中
        • Kunming Yan'an Hospital
        • 首席研究员：
          • Huanjun Chen
  • 希腊
      • Thessaloniki、希腊、GR54635
        • 招聘中
        • "G. Gennimatas" Thessaloniki General Hospital
        • 接触：
        • 首席研究员：
          • Georgios A. Pitoulias, MD, PhD
  • 德国
      • Münster、德国、48149
        • 招聘中
        • Universitätsklinikum Münster (UKM)
        • 接触：
        • 首席研究员：
          • Alexander Oberhuber, Dr. med. univ.
    • Allgäu
      • Immenstadt im Allgäu、Allgäu、德国、87439
  • 意大利
      • Brescia、意大利、25123
        • 尚未招聘
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (ASST Spedali Civili di Brescia)
        • 接触：
        • 首席研究员：
          • Luca Bertoglio
  • 荷兰
      • Rotterdam、荷兰、3015 GD
        • 招聘中
        • Erasmus MC
        • 首席研究员：
          • Hence Verhagen, MD, PhD
        • 接触：
  • 西班牙
    • Catalonia
      • Girona、Catalonia、西班牙、17007
        • 尚未招聘
        • Hospital Universitari de Girona Doctor Josep Trueta
        • 接触：
          • Omar Andrés Navarro, MD, PhD
          • 电话号码：0034972940294
          • 邮箱：cirvasc@gmail.com
        • 接触：
        • 首席研究员：
          • Omar Andrés Navarro, MD, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Chinese and European subjects suffering abdominal aortic aneurysm with a proximal neck length ≥15mm.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
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.
设备：Implantation with Minos Stent graft
Treatment 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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Technical success rate at 12 months
大体时间：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.
12 months

次要结果测量

结果测量
措施说明
大体时间
Incidence of major adverse events at 30 days
大体时间：30 days
30 days
Immediate technical success
大体时间：within 24 hours post-implantation
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.
within 24 hours post-implantation
Incidence of successful aneurysm treatment at 2-5 years
大体时间：Years 2-5 post-implantation
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.
Years 2-5 post-implantation
All-cause mortality up to 5 years post-procedure
大体时间：From implantation to the end of follow up at 5 years
From implantation to the end of follow up at 5 years
Aortic aneurysm related mortality up to 5 years post-procedure
大体时间：From implantation to the end of follow up at 5 years
From implantation to the end of follow up at 5 years
Secondary intervention rates up to 5 years post-procedure
大体时间：From implantation to the end of follow up at 5 years
Secondary intervention rates up to 5 years after TEVAR are measured by tracking all subsequent open and endovascular procedures required to treat device-related or aortic complications. This includes Open surgery: performed at any time to address a failure of endovascular treatment due to failure of stent implantation or placement, complications or other clinical conditions, or after the initial success of endovascular treatment, and Secondary endovascular intervention: any intravascular surgical intervention performed to resolve complications such as endoleak, aneurysm expansion, stent occlusion, stent migration and stent defect after the implantation of Minos™ system.
From implantation to the end of follow up at 5 years
Aneurysm diameter and variation in aneurysm diameter from 30 days to 5 years post-procedure
大体时间：From 30 days post-implantation until end of follow up at 5 years
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
大体时间：From 30 days post-implantation until end of follow up at 5 years
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
大体时间：From 30 days post-implantation until end of follow up at 5 years
From 30 days post-implantation until end of follow up at 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

调查人员

  • 研究主任：Jing Wang、Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年3月5日

初级完成 (估计的)

2028年10月22日

研究完成 (估计的)

2033年1月22日

研究注册日期

首次提交

2026年5月20日

首先提交符合 QC 标准的

2026年6月23日

首次发布 (实际的)

2026年6月29日

研究记录更新

最后更新发布 (实际的)

2026年6月29日

上次提交的符合 QC 标准的更新

2026年6月23日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PMCF-2020-12

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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