Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent GraftPEARLNCT07674173
Post-market European & Asian Registry to Evaluate the Minos™ Stent-Graft and Delivery System in Abdominal Aortic Aneurysm Treatment
An observational study of Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft, run by Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd at 16 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft
- What is being tested?
- Implantation with Minos Stent graft
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 5 Mar 2023to 22 Jan 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese and European subjects suffering abdominal aortic aneurysm with a proximal neck length ≥15mm.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 6 countries
China10 sites, 10 recruiting
- Recruiting
Fuwai Hospital
Beijing, 100037
Chang Shu
- Recruiting
TEDA International Cardiovascular Hospital
Binhai, Tianjin Municipality, 300457
Xuedong Li
- Recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410002
Qing Wang
- Recruiting
Kunming Yan'an Hospital
Kunming, Yunnan, 650051
Huanjun Chen
- Recruiting
The Second Hospital of Lanzhou University
Lanzhou, Gansu, 730030
Dong Zhou
- Recruiting
Meizhou People's Hospital
Meizhou, Guangdong, 514031
Cunren Li
- Recruiting
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, 518053
Minxin Wei
- Recruiting
Xiangtan Central Hospital
Xiangtan, Hunan, 411100
Zhihong Fang
- Recruiting
Yueyang Central Hospital
Yueyang, Hunan, 414000
Yi You
- Recruiting
Zibo Central Hospital
Zibo, Shandong, 255024
Xinming Yu
Germany2 sites, 2 recruiting
- Recruiting
Klinikverbund Allgäu
Immenstadt im Allgäu, Allgäu, 87439
Roland Tines, +49083239108909, Roland.Tines@klinikverbund-allgaeu.de
Roland Tines
- Recruiting
Universitätsklinikum Münster (UKM)
Münster, 48149
Jana Ebing, 00492518351717, vital@ukmuenster.de
Alexander Oberhuber, Dr. med. univ.
Greece1 site, 1 recruiting
- Recruiting
"G. Gennimatas" Thessaloniki General Hospital
Thessaloniki, GR54635
Georgios A. Pitoulias, 00302310992564, pitoulias@yahoo.com
Georgios A. Pitoulias, MD, PhD
Italy1 site, 1 recruiting
- Not yet recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (ASST Spedali Civili di Brescia)
Brescia, 25123
Dipartimento di Chirurgia dell'ASST Spedali Civili di Brescia, 0039303995612, chirurgia.vascolare@asst-spedalicivili.it
Luca Bertoglio
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, 3015 GD
Emmy Muller-Sloof, PhD, 0031107040704, e.muller-sloof@erasmusmc.nl
Hence Verhagen, MD, PhD
Spain1 site, 1 recruiting
- Not yet recruiting
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Catalonia, 17007
Omar Andrés Navarro, MD, PhD, 0034972940294, cirvasc@gmail.com
vascular.girona.ics@gencat.cat
About this study
Official title: 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.
- Conditions
- Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft
- Being tested
- Implantation with Minos Stent graft
- Keywords
- Minos™ Abdominal Aortic Stent-Graft and Delivery System, EVAR, abdominal aortic aneurysm (AAA)
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation with Minos Stent graftDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Implantation with Minos Stent graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (9)
Incidence of major adverse events at 30 days
Measured: 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.
Measured: 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.
Measured: Years 2-5 post-implantation
All-cause mortality up to 5 years post-procedure
Measured: From implantation to the end of follow up at 5 years
Aortic aneurysm related mortality up to 5 years post-procedure
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: From 30 days post-implantation until end of follow up at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start5 Mar 2023
- Primary completion22 Oct 2028 (estimated)
- Study completion22 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Wang, Study director, Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674173
- Sponsor's protocol ID
- PMCF-2020-12
- Acronym
- PEARL
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-centre Observational Real-world Post-market European & Asian Registry With Low-profile Minos™ Abdominal Aortic Stent Graft
- ClinicalTrials.gov ID
- NCT07674173
- Acronym / sponsor ID
- PEARL / PMCF-2020-12
- Conditions
- Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft
- Keywords
- Minos™ Abdominal Aortic Stent-Graft and Delivery System, EVAR, abdominal aortic aneurysm (AAA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 22 Oct 2028 (estimated)
- Study completion
- 22 Jan 2033 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEARL participants | – | Device: Implantation with Minos Stent graftAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese and European subjects suffering abdominal aortic aneurysm with a proximal neck length ≥15mm.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation with Minos Stent graftTreatment 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. | Device | PEARL participants |
Primary outcome
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.
9 secondary outcomes
Incidence of major adverse events at 30 days
Time frame: 30 days
Immediate technical success
Time frame: within 24 hours post-implantation
Incidence of successful aneurysm treatment at 2-5 years
Time frame: Years 2-5 post-implantation
All-cause mortality up to 5 years post-procedure
Time frame: From implantation to the end of follow up at 5 years
Aortic aneurysm related mortality 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 post-procedure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From 30 days post-implantation until end of follow up at 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Wang study director
Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft, run by Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China, Germany, Greece, Italy, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maggie Shen, MD MSc (00441235750800, maggie.shen@endovastec-lm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.