N/A
Completed N=178
Endurant Stent Graft System Post Approval Study (ENGAGE PAS)
Aortic Aneurysm, Abdominal
Source: ClinicalTrials.gov NCT01379222 ↗
Enrolled (actual)
178
Serious AEs
48.3%
Results posted
Feb 2019
Primary outcomePrimary: Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days) — 0.989 Proportion of Surviving
Summary
The purpose of the study is to demonstrate the long term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment, through the endpoints established in this protocol.
The clinical objective of the study is to evaluate the long term safety and effectiveness of the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality (ARM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days) |
0.989 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Indication for elective surgical repair of abdominal aortic aneurysm (AAA) with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System
- Signed consent form. The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information
- Intention to electively implant the Endurant Stent Graft System
- Ability and willingness to comply with the Clinical Investigational Plan (CIP).
Exclusion Criteria
- High probability of non-adherence to physician's follow-up requirements
- Current participation in a concurrent trial which may confound study results
- Female of childbearing potential in whom pregnancy cannot be excluded or who is lactating.
Data sourced from ClinicalTrials.gov (NCT01379222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.