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NCT Number: NCT07674173

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

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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Key information

Conditions

Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Hospital of Lanzhou University, Lanzhou, Gansu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Technical success rate at 12 months

    Time frame: 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 outcomes

  1. Incidence of major adverse events at 30 days

    Time frame: 30 days

  2. Immediate technical success

    Time frame: 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.

  3. Incidence of successful aneurysm treatment at 2-5 years

    Time frame: 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.

  4. All-cause mortality up to 5 years post-procedure

    Time frame: From implantation to the end of follow up at 5 years

  5. Aortic aneurysm related mortality up to 5 years post-procedure

    Time frame: From implantation to the end of follow up at 5 years

  6. Secondary intervention rates 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 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.

  7. 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

  8. 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

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Woodman

CONTACT

[email protected]

00441235750800

Maggie Shen, MD MSc

CONTACT

[email protected]

00441235750800

Sponsors and collaborators

Lead sponsor

Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

Industry

Registry information

Official study title

A Prospective Multi-centre Observational Real-world Post-market European & Asian Registry With Low-profile Minos™ Abdominal Aortic Stent Graft

Acronym: PEARL

Important dates

Study start
2023
Primary completion
2028
Study completion
2033
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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