Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

23. juni 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. mars 2023

Primær fullføring (Antatt)

22. oktober 2028

Studiet fullført (Antatt)

22. januar 2033

Datoer for studieregistrering

Først innsendt

20. mai 2026

Først innsendt som oppfylte QC-kriteriene

23. juni 2026

Først lagt ut (Faktiske)

29. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PMCF-2020-12

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere