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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. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Grækenland
      • Thessaloniki, Grækenland, GR54635
        • Rekruttering
        • "G. Gennimatas" Thessaloniki General Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Georgios A. Pitoulias, MD, PhD
  • Holland
      • Rotterdam, Holland, 3015 GD
        • Rekruttering
        • Erasmus MC
        • Ledende efterforsker:
          • Hence Verhagen, MD, PhD
        • Kontakt:
  • Italien
      • Brescia, Italien, 25123
        • Ikke rekrutterer endnu
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (ASST Spedali Civili di Brescia)
        • Kontakt:
        • Ledende efterforsker:
          • Luca Bertoglio
  • Kina
      • Beijing, Kina, 100037
        • Rekruttering
        • Fuwai Hospital
        • Ledende efterforsker:
          • Chang Shu
    • Gansu
      • Lanzhou, Gansu, Kina, 730030
        • Rekruttering
        • The Second Hospital of Lanzhou University
        • Ledende efterforsker:
          • Dong Zhou
    • Guangdong
      • Meizhou, Guangdong, Kina, 514031
        • Rekruttering
        • Meizhou People's Hospital
        • Ledende efterforsker:
          • Cunren Li
      • Shenzhen, Guangdong, Kina, 518053
        • Rekruttering
        • The University of Hong Kong - Shenzhen Hospital
        • Ledende efterforsker:
          • Minxin Wei
    • Hunan
      • Changsha, Hunan, Kina, 410002
        • Rekruttering
        • Hunan Provincial People's Hospital
        • Ledende efterforsker:
          • Qing Wang
      • Xiangtan, Hunan, Kina, 411100
        • Rekruttering
        • Xiangtan Central Hospital
        • Ledende efterforsker:
          • Zhihong Fang
      • Yueyang, Hunan, Kina, 414000
        • Rekruttering
        • Yueyang Central Hospital
        • Ledende efterforsker:
          • Yi You
    • Shandong
      • Zibo, Shandong, Kina, 255024
        • Rekruttering
        • Zibo Central Hospital
        • Ledende efterforsker:
          • Xinming Yu
    • Tianjin Municipality
      • Binhai, Tianjin Municipality, Kina, 300457
        • Rekruttering
        • Teda International Cardiovascular Hospital
        • Ledende efterforsker:
          • Xuedong Li
    • Yunnan
      • Kunming, Yunnan, Kina, 650051
        • Rekruttering
        • Kunming Yan'an Hospital
        • Ledende efterforsker:
          • Huanjun Chen
  • Spanien
    • Catalonia
      • Girona, Catalonia, Spanien, 17007
        • Ikke rekrutterer endnu
        • Hospital Universitari de Girona Doctor Josep Trueta
        • Kontakt:
          • Omar Andrés Navarro, MD, PhD
          • Telefonnummer: 0034972940294
          • E-mail: cirvasc@gmail.com
        • Kontakt:
        • Ledende efterforsker:
          • Omar Andrés Navarro, MD, PhD
  • Tyskland
      • Münster, Tyskland, 48149
        • Rekruttering
        • Universitätsklinikum Münster (UKM)
        • Kontakt:
        • Ledende efterforsker:
          • Alexander Oberhuber, Dr. med. univ.
    • Allgäu
      • Immenstadt im Allgäu, Allgäu, Tyskland, 87439

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Technical success rate at 12 months
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of major adverse events at 30 days
Tidsramme: 30 days
30 days
Immediate technical success
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

Efterforskere

  • Studieleder: Jing Wang, Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. marts 2023

Primær færdiggørelse (Anslået)

22. oktober 2028

Studieafslutning (Anslået)

22. januar 2033

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

23. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PMCF-2020-12

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

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