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

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.

Study Overview

• Status: Recruiting
• Conditions: Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft
• Intervention / Treatment: Device: Implantation with Minos Stent graft

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Maggie Shen, MD MSc; Phone Number: 00441235750800; Email: maggie.shen@endovastec-lm.com
• Study Contact Backup: Name: Anne Woodman; Phone Number: 00441235750800; Email: anne.woodman@endovastec-lm.com

Study Locations

• China
  • Beijing, China, 100037
    • Recruiting
    • Fuwai Hospital
    • Principal Investigator: Chang Shu
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Recruiting
      • The Second Hospital of Lanzhou University
      • Principal Investigator: Dong Zhou
  • Guangdong
    • Meizhou, Guangdong, China, 514031
      • Recruiting
      • Meizhou People's Hospital
      • Principal Investigator: Cunren Li
    • Shenzhen, Guangdong, China, 518053
      • Recruiting
      • The University of Hong Kong - Shenzhen Hospital
      • Principal Investigator: Minxin Wei
  • Hunan
    • Changsha, Hunan, China, 410002
      • Recruiting
      • Hunan Provincial People's Hospital
      • Principal Investigator: Qing Wang
    • Xiangtan, Hunan, China, 411100
      • Recruiting
      • Xiangtan Central Hospital
      • Principal Investigator: Zhihong Fang
    • Yueyang, Hunan, China, 414000
      • Recruiting
      • Yueyang Central Hospital
      • Principal Investigator: Yi You
  • Shandong
    • Zibo, Shandong, China, 255024
      • Recruiting
      • Zibo Central Hospital
      • Principal Investigator: Xinming Yu
  • Tianjin Municipality
    • Binhai, Tianjin Municipality, China, 300457
      • Recruiting
      • TEDA International Cardiovascular Hospital
      • Principal Investigator: Xuedong Li
  • Yunnan
    • Kunming, Yunnan, China, 650051
      • Recruiting
      • Kunming Yan'an Hospital
      • Principal Investigator: Huanjun Chen
• Germany
  • Münster, Germany, 48149
    • Recruiting
    • Universitätsklinikum Münster (UKM)
    • Contact: Jana Ebing; Phone Number: 00492518351717; Email: vital@ukmuenster.de
    • Principal Investigator: Alexander Oberhuber, Dr. med. univ.
  • Allgäu
    • Immenstadt im Allgäu, Allgäu, Germany, 87439
      • Recruiting
      • Klinikverbund Allgäu
      • Contact: Roland Tines; Phone Number: +49083239108909; Email: Roland.Tines@klinikverbund-allgaeu.de
      • Principal Investigator: Roland Tines
• Greece
  • Thessaloniki, Greece, GR54635
    • Recruiting
    • "G. Gennimatas" Thessaloniki General Hospital
    • Contact: Georgios A. Pitoulias; Phone Number: 00302310992564; Email: pitoulias@yahoo.com
    • Principal Investigator: Georgios A. Pitoulias, MD, PhD
• Italy
  • Brescia, Italy, 25123
    • Not yet recruiting
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (ASST Spedali Civili di Brescia)
    • Contact: Dipartimento di Chirurgia dell'ASST Spedali Civili di Brescia; Phone Number: 0039303995612; Email: chirurgia.vascolare@asst-spedalicivili.it
    • Principal Investigator: Luca Bertoglio
• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Recruiting
    • Erasmus MC
    • Principal Investigator: Hence Verhagen, MD, PhD
    • Contact: Emmy Muller-Sloof, PhD; Phone Number: 0031107040704; Email: e.muller-sloof@erasmusmc.nl
• Spain
  • Catalonia
    • Girona, Catalonia, Spain, 17007
      • Not yet recruiting
      • Hospital Universitari de Girona Doctor Josep Trueta
      • Contact: Omar Andrés Navarro, MD, PhD; Phone Number: 0034972940294; Email: cirvasc@gmail.com
      • Contact: Email: vascular.girona.ics@gencat.cat
      • Principal Investigator: Omar Andrés Navarro, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
• Investigators: Study Director: Jing Wang, Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2023
• Primary Completion (Estimated): October 22, 2028
• Study Completion (Estimated): January 22, 2033

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: EVAR; Minos™ Abdominal Aortic Stent-Graft and Delivery System; abdominal aortic aneurysm (AAA)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: PMCF-2020-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES