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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation with Minos Stent graft | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate at 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse events at 30 days | 30 days | |
| Immediate technical success | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese and European subjects suffering abdominal aortic aneurysm with a proximal neck length ≥15mm.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maggie Shen, MD MSc | Contact | 00441235750800 | maggie.shen@endovastec-lm.com | |
| Anne Woodman | Contact | 00441235750800 | anne.woodman@endovastec-lm.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Wang | Shanghai MicroPort Endovascular MedTech(Group)Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | 730030 | China |
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| within 24 hours post-implantation |
| Incidence of successful aneurysm treatment at 2-5 years | 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 | 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 | 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 | 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 |
| Meizhou People's Hospital | Recruiting | Meizhou | Guangdong | 514031 | China |
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| The University of Hong Kong - Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | 518053 | China |
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| Hunan Provincial People's Hospital | Recruiting | Changsha | Hunan | 410002 | China |
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| Xiangtan Central Hospital | Recruiting | Xiangtan | Hunan | 411100 | China |
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| Yueyang Central Hospital | Recruiting | Yueyang | Hunan | 414000 | China |
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| Zibo Central Hospital | Recruiting | Zibo | Shandong | 255024 | China |
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| TEDA International Cardiovascular Hospital | Recruiting | Binhai | Tianjin Municipality | 300457 | China |
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| Kunming Yan'an Hospital | Recruiting | Kunming | Yunnan | 650051 | China |
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| Fuwai Hospital | Recruiting | Beijing | 100037 | China |
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| Klinikverbund Allgäu | Recruiting | Immenstadt im Allgäu | Allgäu | 87439 | Germany |
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| Universitätsklinikum Münster (UKM) | Recruiting | Münster | 48149 | Germany |
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| "G. Gennimatas" Thessaloniki General Hospital | Recruiting | Thessaloniki | GR54635 | Greece |
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| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (ASST Spedali Civili di Brescia) | Not yet recruiting | Brescia | 25123 | Italy |
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| Erasmus MC | Recruiting | Rotterdam | 3015 GD | Netherlands |
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| Hospital Universitari de Girona Doctor Josep Trueta | Not yet recruiting | Girona | Catalonia | 17007 | Spain |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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