Status:
ACTIVE_NOT_RECRUITING
Endurant CHevAr New Indication Trial: ENCHANT
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
AAA - Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Brief 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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 26 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03320252
Start Date
October 26 2017
End Date
July 1 2030
Last Update
September 18 2025
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Ordensklinikum Linz GmbH / Elisabethinen
Linz, Austria, 4010
2
CHU de Bordeaux - Centre Universitaire Pellegrin
Bordeaux, France, 33000
3
Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré
Boulogne-Billancourt, France, 92104
4
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09116