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Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE)

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ClinicalTrials.gov Identifier: NCT00870051
Recruitment Status : Active, not recruiting
First Posted : March 26, 2009
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Study Design

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endurant Stent Graft Natural Selection Global Postmarket Registry
Study Start Date : March 2009
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Treatment success 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: 10 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00870051


Locations
Australia
The Queen Elizabeth Hospital
Adelaide, Australia, SA 5011
Sponsors and Collaborators
Medtronic Endovascular
Investigators
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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00870051     History of Changes
Other Study ID Numbers: P#888
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Medtronic Endovascular:
Endurant
Stent Graft
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases