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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 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

200

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Technical success rate at 12 months
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of major adverse events at 30 days
Tidsram: 30 days
30 days
Immediate technical success
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 mars 2023

Primärt slutförande (Beräknad)

22 oktober 2028

Avslutad studie (Beräknad)

22 januari 2033

Studieregistreringsdatum

Först inskickad

20 maj 2026

Först inskickad som uppfyllde QC-kriterierna

23 juni 2026

Första postat (Faktisk)

29 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PMCF-2020-12

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

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