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Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870051
First Posted: March 26, 2009
Last Update Posted: February 2, 2017
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.
Information provided by (Responsible Party):
Medtronic Endovascular
March 25, 2009
March 26, 2009
February 2, 2017
March 2009
October 2021   (Final data collection date for primary outcome measure)
Treatment success Treatment Success [ Time Frame: 10 years ]
The proportion of subjects who experience a treatment success at 12 months post-implantation [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00870051 on ClinicalTrials.gov Archive Site
  • 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 ]
  • The proportion of subjects who are free from stent graft migration [ Time Frame: 12 months ]
  • The proportion of subjects who are free from stent graft patency [ Time Frame: 12 months ]
  • The proportion of subjects who are free from stent graft endoleaks [ Time Frame: 30 days ]
  • The proportion of subjects who are free from secondary procedures to correct Type I and III endoleaks [ Time Frame: 12 months ]
  • The proportion of subjects who are free from secondary endovascular procedure [ Time Frame: 12 months ]
  • The proportion of subjects who are free from adverse device effects [ Time Frame: 12 months ]
Not Provided
Not Provided
 
Endurant Stent Graft Natural Selection Global Postmarket Registry
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Subjects diagnosed with an AAA who are considered candidates for endovascular
Aortic Aneurysm, Abdominal
Device: Endurant Stent Graft
Endurant Stent Graft implantation
Other Name: EVAR
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
Intervention: Device: Endurant Stent Graft

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1200
October 2021
October 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00870051
P#888
No
Not Provided
Plan to Share IPD: Undecided
Medtronic Endovascular
Medtronic Endovascular
Not Provided
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
Medtronic Endovascular
January 2017