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

23 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Estimado)

200

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Alemania
      • Münster, Alemania, 48149
        • Reclutamiento
        • Universitätsklinikum Münster (UKM)
        • Contacto:
        • Investigador principal:
          • Alexander Oberhuber, Dr. med. univ.
    • Allgäu
      • Immenstadt im Allgäu, Allgäu, Alemania, 87439
        • Reclutamiento
        • Klinikverbund Allgäu
        • Contacto:
        • Investigador principal:
          • Roland Tines
  • España
    • Catalonia
      • Girona, Catalonia, España, 17007
        • Aún no reclutando
        • Hospital Universitari de Girona Doctor Josep Trueta
        • Contacto:
          • Omar Andrés Navarro, MD, PhD
          • Número de teléfono: 0034972940294
          • Correo electrónico: cirvasc@gmail.com
        • Contacto:
        • Investigador principal:
          • Omar Andrés Navarro, MD, PhD
  • Grecia
      • Thessaloniki, Grecia, GR54635
        • Reclutamiento
        • "G. Gennimatas" Thessaloniki General Hospital
        • Contacto:
          • Georgios A. Pitoulias
          • Número de teléfono: 00302310992564
          • Correo electrónico: pitoulias@yahoo.com
        • Investigador principal:
          • Georgios A. Pitoulias, MD, PhD
  • Italia
      • Brescia, Italia, 25123
        • Aún no reclutando
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (ASST Spedali Civili di Brescia)
        • Contacto:
        • Investigador principal:
          • Luca Bertoglio
  • Países Bajos
      • Rotterdam, Países Bajos, 3015 GD
        • Reclutamiento
        • Erasmus MC
        • Investigador principal:
          • Hence Verhagen, MD, PhD
        • Contacto:
  • Porcelana
      • Beijing, Porcelana, 100037
        • Reclutamiento
        • Fuwai Hospital
        • Investigador principal:
          • Chang Shu
    • Gansu
      • Lanzhou, Gansu, Porcelana, 730030
        • Reclutamiento
        • The Second Hospital of Lanzhou University
        • Investigador principal:
          • Dong Zhou
    • Guangdong
      • Meizhou, Guangdong, Porcelana, 514031
        • Reclutamiento
        • Meizhou People's Hospital
        • Investigador principal:
          • Cunren Li
      • Shenzhen, Guangdong, Porcelana, 518053
        • Reclutamiento
        • The University of Hong Kong - Shenzhen Hospital
        • Investigador principal:
          • Minxin Wei
    • Hunan
      • Changsha, Hunan, Porcelana, 410002
        • Reclutamiento
        • Hunan Provincial People's Hospital
        • Investigador principal:
          • Qing Wang
      • Xiangtan, Hunan, Porcelana, 411100
        • Reclutamiento
        • Xiangtan Central Hospital
        • Investigador principal:
          • Zhihong Fang
      • Yueyang, Hunan, Porcelana, 414000
        • Reclutamiento
        • Yueyang Central Hospital
        • Investigador principal:
          • Yi You
    • Shandong
      • Zibo, Shandong, Porcelana, 255024
        • Reclutamiento
        • Zibo Central Hospital
        • Investigador principal:
          • Xinming Yu
    • Tianjin Municipality
      • Binhai, Tianjin Municipality, Porcelana, 300457
        • Reclutamiento
        • TEDA International Cardiovascular Hospital
        • Investigador principal:
          • Xuedong Li
    • Yunnan
      • Kunming, Yunnan, Porcelana, 650051
        • Reclutamiento
        • Kunming Yan'an Hospital
        • Investigador principal:
          • Huanjun Chen

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Dispositivo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Technical success rate at 12 months
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of major adverse events at 30 days
Periodo de tiempo: 30 days
30 days
Immediate technical success
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

Investigadores

  • Director de estudio: Jing Wang, Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de marzo de 2023

Finalización primaria (Estimado)

22 de octubre de 2028

Finalización del estudio (Estimado)

22 de enero de 2033

Fechas de registro del estudio

Enviado por primera vez

20 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de junio de 2026

Publicado por primera vez (Actual)

29 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PMCF-2020-12

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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