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Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00870051
Recruitment Status : Active, not recruiting
First Posted : March 26, 2009
Last Update Posted : January 22, 2021
Information provided by (Responsible Party):
Medtronic Endovascular

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

Condition or disease Intervention/treatment
Aortic Aneurysm, Abdominal Device: Endurant Stent Graft

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.

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Study Type : Observational
Actual Enrollment : 1266 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endurant Stent Graft Natural Selection Global Postmarket Registry
Actual Study Start Date : April 8, 2009
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Treatment Success [ Time Frame: 10 years ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00870051

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Sponsors and Collaborators
Medtronic Endovascular
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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
Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medtronic Endovascular Identifier: NCT00870051    
Other Study ID Numbers: P#888
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only multi center data will be available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medtronic Endovascular:
Stent Graft
Abdominal Aortic Aneurysm
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases