Recruiting NCT07674173
Post-market European & Asian Registry to Evaluate the Minos™ Stent-Graft and Delivery System in Abdominal Aortic Aneurysm Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implantation with Minos Stent graft.
- Who it may be relevant to
- Registry conditions: Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China, Germany, Greece, Italy, Netherlands +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Multi-centre Observational Real-world Post-market European & Asian Registry With Low-profile Minos™ Abdominal Aortic Stent Graft
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Technical success rate at 12 months [Time frame: 12 months]
Secondary outcome measures (9)
- Incidence of major adverse events at 30 days [Time frame: 30 days]
- Immediate technical success [Time frame: within 24 hours post-implantation]
- Incidence of successful aneurysm treatment at 2-5 years [Time frame: Years 2-5 post-implantation]
- All-cause mortality up to 5 years post-procedure [Time frame: From implantation to the end of follow up at 5 years]
- Aortic aneurysm related mortality up to 5 years post-procedure [Time frame: From implantation to the end of follow up at 5 years]
- Secondary intervention rates up to 5 years post-procedure [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From 30 days post-implantation until end of follow up at 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 10 centers
- The Second Hospital of Lanzhou University — Lanzhou
- Meizhou People's Hospital — Meizhou
- The University of Hong Kong - Shenzhen Hospital — Shenzhen
- Hunan Provincial People's Hospital — Changsha
- Xiangtan Central Hospital — Xiangtan
- Yueyang Central Hospital — Yueyang
- Zibo Central Hospital — Zibo
- TEDA International Cardiovascular Hospital — Binhai
- … and 2 more centers
Germany · 2 centers
- Klinikverbund Allgäu — Immenstadt im Allgäu
- Universitätsklinikum Münster (UKM) — Münster
Greece · 1 center
- "G. Gennimatas" Thessaloniki General Hospital — Thessaloniki
Italy · 1 center
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (ASST Spedali Civili — Brescia
Netherlands · 1 center
- Erasmus MC — Rotterdam
Spain · 1 center
- Hospital Universitari de Girona Doctor Josep Trueta — Girona
Identifiers
NCT: NCT07674173 · PMCF-2020-12