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Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic Endovascular Identifier:
First received: March 25, 2009
Last updated: February 1, 2017
Last verified: January 2017
The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.

Condition Intervention
Aortic Aneurysm, Abdominal
Device: Endurant Stent Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endurant Stent Graft Natural Selection Global Postmarket Registry

Resource links provided by NLM:

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Treatment success Treatment Success [ Time Frame: 10 years ]

Secondary Outcome Measures:
  • 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 ]
    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.

  • AAA Diameter Increase [ Time Frame: 10 years ]

Estimated Enrollment: 1200
Study Start Date: March 2009
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
AAA patients
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
Device: Endurant Stent Graft
Endurant Stent Graft implantation
Other Name: EVAR

Detailed 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects diagnosed with an AAA who are considered candidates for endovascular

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00870051

The Queen Elizabeth Hospital
Adelaide, Australia, SA 5011
Sponsors and Collaborators
Medtronic Endovascular
Study Director: Vicente Riambau, Prof. Hospital Clinic of Barcelona
Study Director: Furuzan Numan, prof Memorial Hospital Istanbul
Study Director: Robert A. Fitridge, Dr. The Queen Elizabeth Hospital, Woodville, South Adelaide, Australia
Study Director: Yehuda Wolf, Prof. Tel Aviv Sourasky Medical Center, Israel
Study Director: Dittmar Böckler, Prof. Universtiy of Heidelberg, Germany
Study Director: Paul Hayes, Dr. Addenbrookes Hospital, Cambridge, Great Britain
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Endovascular Identifier: NCT00870051     History of Changes
Other Study ID Numbers: P#888
Study First Received: March 25, 2009
Last Updated: February 1, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Medtronic Endovascular:
Stent Graft
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on April 25, 2017