Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
150 participants
OBSERVATIONAL
2017-10-26
2030-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)
NCT01526811
Endurant Stent Graft System Post Approval Study (ENGAGE PAS)
NCT01379222
Endurant Evo International Clinical Trial
NCT02461524
Endurant Evo US Clinical Trial
NCT02393716
Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
NCT05378347
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Endurant Chimney Graft Technique
Medtronic Endurant II and Endurant IIs Stent Graft Systems and balloon-expandable covered stent graft systems approved for use in the renal arteries. These devices will be utilized in a chimney graft configuration.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject is scheduled for primary treatment of the juxtarenal aortic aneurysm with a short infrarenal neck (i.e. no revision subjects)
* Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
* Subject has provided written informed consent
* Subject is an eligible candidate according to the currently available Endurant II/IIs instructions for use for ChEVAR
* Subject has a juxtarenal aortic aneurysm with a short infrarenal neck (definition of juxtarenal aortic aneurysm with a short infrarenal neck will be in accordance with commercially available Endurant II/IIs instructions for use for ChEVAR).
Exclusion Criteria
* 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. Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-19. Subjects with a positive COVID-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 6 months prior to enrollment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Cardiovascular
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ordensklinikum Linz GmbH / Elisabethinen
Linz, , Austria
CHU de Bordeaux - Centre Universitaire Pellegrin
Bordeaux, , France
Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré
Boulogne-Billancourt, , France
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Elisabeth Krankenhaus Essen GmbH
Essen, , Germany
Universitäts Klinikum Frankfurt - Goethe-Universität
Frankfurt am Main, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
St. Franziskus-Hospital Münster GmbH
Münster, , Germany
Evaggelismos General Hospital of Athens
Athens, , Greece
University Hospital of Larissa
Larissa, , Greece
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, , Greece
Azienda Ospedaliera di Cosenza
Cosenza, , Italy
Ospedale Civile Sant'Andrea
La Spezia, , Italy
Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo
Roma, , Italy
Stichting Rijnstate Ziekenhuis
Arnhem, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Zuyderland Medisch Centrum
Heerlen, , Netherlands
Hospital de Santa Marta
Lisbon, , Portugal
Russian Cardiologic Research and Production Complex, Russian Ministry of Health
Moscow, , Russia
CINRE s.r.o.
Bratislava, , Slovakia
Hospital Clinic de Barcelona
Barcelona, , Spain
Corporacío Parc Taulí - Hospital de Sabadell
Sabadell, , Spain
Skånes Universitetssjukhus Malmö
Malmo, , Sweden
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, , Switzerland
St George's University Hospitals - NHS Trust
London, , United Kingdom
Central Manchester University Hospitals NHS - Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MDT16022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.