Endurant CHevAr New Indication Trial: ENCHANT

Last updated: May 15, 2025
Sponsor: Medtronic Cardiovascular
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heart Disease

Aneurysm

Cardiovascular Disease

Treatment

Endurant Chimney Graft Technique

Clinical Study ID

NCT03320252
MDT16022
  • Ages > 18
  • All Genders

Study Summary

The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is ≥18 years old

  • Subject is scheduled for primary treatment of the juxtarenal aortic aneurysm with ashort infrarenal neck (i.e. no revision subjects)

  • Subject is able and willing to comply with the protocol and to adhere to thefollow-up requirements

  • Subject has provided written informed consent

  • Subject is an eligible candidate according to the currently available EndurantII/IIs instructions for use for ChEVAR

  • Subject has a juxtarenal aortic aneurysm with a short infrarenal neck (definition ofjuxtarenal aortic aneurysm with a short infrarenal neck will be in accordance withcommercially available Endurant II/IIs instructions for use for ChEVAR).

Exclusion

Exclusion Criteria:

  • Subject is participating in a concurrent study which may confound study results

  • Subject has a life expectancy ≤ 2 year

  • Subject has an aneurysm that is:

  • Suprarenal or pararenal

  • Isolated iliofemoral

  • Mycotic

  • Inflammatory

  • Pseudoaneurysm

  • Subject requires emergent aneurysm treatment, for example, trauma or rupture

  • Subject has previously undergone surgical treatment for abdominal aortic aneurysm

  • Subject is a female of childbearing potential in whom pregnancy cannot be excluded

  • Subject has a known hypersensitivity or contraindication to anticoagulants,anti-platelets, or contrast media, which is not amenable to pre-treatment

  • Subject has a creatinine level >2.0 mg/dl (or >176.8 μmol/L) and/or is on dialysis

  • Subject has an active COVID-19 infection or relevant history of COVID-19. Relevanthistory of COVID-19 is defined as availability of a positive COVID-19 test withsequela or hospitalization for treatment of COVID-19. Subjects with a positiveCOVID-19 test who were asymptomatic or had mild symptoms should be excluded only ifthe positive test was less than 6 months prior to enrollment

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Endurant Chimney Graft Technique
Phase:
Study Start date:
October 26, 2017
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • Ordensklinikum Linz GmbH / Elisabethinen

    Linz, 4010
    Austria

    Site Not Available

  • CHU de Bordeaux - Centre Universitaire Pellegrin

    Bordeaux, 33000
    France

    Site Not Available

  • Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré

    Boulogne Billancourt, 92104
    France

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116
    Germany

    Site Not Available

  • Elisabeth Krankenhaus Essen GmbH

    Essen, 45138
    Germany

    Site Not Available

  • Universitäts Klinikum Frankfurt - Goethe-Universität

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • Krankenhaus Porz am Rhein gGmbH

    Köln, 51149
    Germany

    Site Not Available

  • St. Franziskus-Hospital Münster GmbH

    Münster, 48145
    Germany

    Site Not Available

  • Evaggelismos General Hospital of Athens

    Athens, 106 76
    Greece

    Site Not Available

  • University Hospital of Larissa

    Larissa, 413 34
    Greece

    Site Not Available

  • Ippokrateio General Hospital of Thessaloniki

    Thessaloniki, 546 42
    Greece

    Site Not Available

  • Galway Clinic

    Galway, H91 HHTO
    Ireland

    Site Not Available

  • Galway University Hospitals - University Hospital Galway (UHG)

    Galway, H91 YR71
    Ireland

    Site Not Available

  • Azienda Ospedaliera di Cosenza

    Cosenza, 87100
    Italy

    Site Not Available

  • Ospedale Civile Sant'Andrea

    La Spezia, 19124
    Italy

    Site Not Available

  • Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo

    Roma, 00152
    Italy

    Site Not Available

  • Stichting Rijnstate Ziekenhuis

    Arnhem, 6815
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede, 7512 KZ
    Netherlands

    Site Not Available

  • Zuyderland Medisch Centrum

    Heerlen, 6419PC
    Netherlands

    Site Not Available

  • Hospital de Santa Marta

    Lisboa, 1169-024
    Portugal

    Site Not Available

  • Russian Cardiologic Research and Production Complex, Russian Ministry of Health

    Moscow, 121552
    Russian Federation

    Site Not Available

  • CINRE s.r.o.

    Bratislava, 85105
    Slovakia

    Site Not Available

  • Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)

    Bratislava 37, 83348
    Slovakia

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Corporacío Parc Taulí - Hospital de Sabadell

    Sabadell, 08208
    Spain

    Site Not Available

  • Skånes Universitetssjukhus Malmö

    Malmö, 205 02
    Sweden

    Site Not Available

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, 1011
    Switzerland

    Site Not Available

  • UniversitätsSpital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • St George's University Hospitals - NHS Trust

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • Central Manchester University Hospitals NHS - Manchester Royal Infirmary

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

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