Skip to main content
OpenTrials
Completed

NCT Number: NCT00870051

Endurant Stent Graft Natural Selection Global Postmarket Registry

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica La Sagrada Familia, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endurant Stent Graft

Device

Endurant Stent Graft implantation

Other names: EVAR

Primary outcomes

  1. Treatment Success

    Time frame: 10 years

Secondary outcomes

  1. Stent Graft Migration

    Time frame: 10 years

  2. Stent Graft Patency

    Time frame: 10 years

  3. Stent Graft Endoleaks

    Time frame: 10 years

  4. Secondary procedures to correct Type I and III endoleaks

    Time frame: 10 years

  5. Secondary endovascular procedure

    Time frame: 10 years

  6. Adverse Device Effects

    Time frame: 10 years

  7. Technical Observations

    Time frame: 5 years

  8. Aneurysm-related mortality

    Time frame: 10 years

  9. All-cause mortality

    Time frame: 10 years

  10. MAE

    Time frame: 30 days

  11. Health Related Quality of Life Scores

    Time frame: 12 months

  12. Stent Graft Stenosis

    Time frame: 10 years

    Stent Graft stenosis is considered a reduction in the diameter of the stent graft lumen as compared to the reference. SG stenosis will be assessed by imaging as CT with contrast, Ultrasound, etc.

  13. AAA Diameter Increase

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Acronym: ENGAGE

Important dates

Study start
2009
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2009
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.