Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft
Conditions
Keywords
Minos™ Abdominal Aortic Stent-Graft and Delivery System, EVAR, abdominal aortic aneurysm (AAA)
Brief summary
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
DEVICEImplantation 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.
Sponsors
Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate at 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse events at 30 days | 30 days | — |
| Immediate technical success | 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. |
| Incidence of successful aneurysm treatment at 2-5 years | 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. |
| 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 | 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. |
| 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 | — |
Countries
China, Germany, Greece, Italy, Netherlands, Spain
Contacts
CONTACTMaggie Shen, MD MSc
CONTACTAnne Woodman
STUDY_DIRECTORJing Wang
Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Outcome results
None listed