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Study Purpose To prospectively collect global ‘real world’ performance data on the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable.
To create a database that can be pooled/compared with the ENGAGE database
Primary Endpoints Treatment Success through given time-points
Secondary Endpoints
Design Multi-centre, post-market, non-interventional, non-randomized, single-arm prospective observational study
Subjects 250 subjects
Inclusion Criteria
i.c.w ≤60˚ infrarenal AND ≤45˚ suprarenal angulation
i.c.w. 60˚-75˚ infrarenal AND ≤60˚ suprarenal angulation
OR i.c.w. ≤75˚ infrarenal AND 45˚-60˚ suprarenal angulation
i.c.w. 75˚-90˚ infrarenal AND ≤75˚ suprarenal angulation
OR i.c.w. ≤90˚ infrarenal AND 60˚-75˚ suprarenal angulation
Exclusion Criteria
Sites 20 high-volume sites across 10 countries worldwide
Site Selection Criteria
Study Duration 7-8 years (2012 to 2020)
2-3 years of Enrolment and 5 years of Follow-up
Anticipated FU Schedule 30-days, 1-year, 2-year, 3-year, 4-year and 5-year post-implant follow-up.
Sponsor Department of Vascular Surgery, Catharina Hospital, (Eindhoven, The Netherlands)
Executive / Publication Committee Members yet to be determined, but will be representatives of Investigators and Sponsor’s study management.
Trial Registration ClinicalTrials.gov Identifier: NCT01810250