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)
Primary safety endpoint evaluated by proportion of subjects experiencing a Major Adverse Event through 30 days post-index procedure — through 30 days post-index procedure Major Adverse Events include the occurrence of any of the following events:
* All-cause mortality
* Bowel ischemia
* Myocardial infarction
* Paraplegia
* Procedural blood loss ≥1000 cc
* Renal failure
* Respiratory failure
* Stroke
The primary performance endpoint is defined as the proportion of subjects who have technical success at the time of the index procedure and are free from secondary interventions through 365 days. — Index procedure and through 365 days
Trial sites (26)
Facility
City
Region
Status
Ordensklinikum Linz GmbH / Elisabethinen
Linz
Austria
CHU de Bordeaux - Centre Universitaire Pellegrin
Bordeaux
France
Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré
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.
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