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Clinical Trials in Germany / NCT03320252
Active, not recruiting Observational

Endurant CHevAr New Indication Trial: ENCHANT

NCT03320252 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2017-10-26
Last updated
2026-06-02

Condition(s) studied

AAA - Abdominal Aortic Aneurysm

Investigational drug(s) / intervention(s)

Endurant Chimney Graft Technique

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.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Subject is ≥18 years old * 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 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. 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

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
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 Malmö 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

More Medtronic Cardiovascular trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03320252 on ClinicalTrials.gov ↗ ← All trials in Germany