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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Technical success rate at 12 months [Срок оценки: 12 months]

Вторичные конечные точки (9)

• Incidence of major adverse events at 30 days [Срок оценки: 30 days]
• Immediate technical success [Срок оценки: within 24 hours post-implantation]
• Incidence of successful aneurysm treatment at 2-5 years [Срок оценки: Years 2-5 post-implantation]
• All-cause mortality up to 5 years post-procedure [Срок оценки: From implantation to the end of follow up at 5 years]
• Aortic aneurysm related mortality up to 5 years post-procedure [Срок оценки: From implantation to the end of follow up at 5 years]
• Secondary intervention rates up to 5 years post-procedure [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From 30 days post-implantation until end of follow up at 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 10 центров

• The Second Hospital of Lanzhou University — Lanzhou
• Meizhou People's Hospital — Meizhou
• The University of Hong Kong - Shenzhen Hospital — Шэньчжэнь
• Hunan Provincial People's Hospital — Чанша
• Xiangtan Central Hospital — Xiangtan
• Yueyang Central Hospital — Yueyang
• Zibo Central Hospital — Zibo
• TEDA International Cardiovascular Hospital — Binhai
• … и ещё 2 центра

Германия · 2 центра

• Klinikverbund Allgäu — Immenstadt im Allgäu
• Universitätsklinikum Münster (UKM) — Münster

Греция · 1 центр

• "G. Gennimatas" Thessaloniki General Hospital — Thessaloniki

Италия · 1 центр

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (ASST Spedali Civili — Brescia

Нидерланды · 1 центр

• Erasmus MC — Rotterdam

Испания · 1 центр

• Hospital Universitari de Girona Doctor Josep Trueta — Girona

Идентификаторы

NCT: NCT07674173 · PMCF-2020-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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