Overview

This trial is active, not recruiting.

Condition aortic aneurysm, abdominal
Treatment endurant stent graft
Sponsor Medtronic Endovascular
Start date March 2009
End date October 2021
Trial size 1200 participants
Trial identifier NCT00870051, P#888

Summary

The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Subjects diagnosed with an AAA who are considered candidates for endovascular repair with Endurant Stent Graft, and who meet the inclusion/exclusion criteria are intended to participate in this registry
endurant stent graft EVAR
Endurant Stent Graft implantation

Primary Outcomes

Measure
Treatment success Treatment Success
time frame: 10 years

Secondary Outcomes

Measure
Stent Graft Migration
time frame: 10 years
Stent Graft Patency
time frame: 10 years
Stent Graft Endoleaks
time frame: 10 years
Secondary procedures to correct Type I and III endoleaks
time frame: 10 years
Secondary endovascular procedure
time frame: 10 years
Adverse Device Effects
time frame: 10 years
Technical Observations
time frame: 10 years
Aneurysm-related mortality
time frame: 10 years
All-cause mortality
time frame: 10 years
MAE
time frame: 30 days
Health Related Quality of Life Scores
time frame: 12 months
Stent Graft Stenosis
time frame: 10 years
AAA Diameter Increase
time frame: 10 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age ≥18 years or minimum age as required by local regulations - Indication for elective surgical repair of 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 ("Patient informed consent Form" or "Patient Data Release Authorization 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 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

Additional Information

Official title Endurant Stent Graft Natural Selection Global Postmarket Registry
Description The Endurant Stent Graft Natural Selection Global Post-market Registry, ENGAGE is initiated to expand the clinical knowledge base by including 'real world' subjects, applying a minimal amount of subject selection criteria. This subject group may better represent the subject profile treated in actual clinical practice without selecting sub-groups of particular low/high risk or excluding certain diseases. ENGAGE aims at following and documenting the subject selections, diagnostic tools used and treatment interventions chosen by the vascular surgeon or interventional radiologist. ENGAGE will not impose CIP required study procedures affecting clinical practice.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Medtronic Endovascular.