Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endurant for Challenging Anatomy: Global Experience Registry (EAGLE)

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.
 
ClinicalTrials.gov Identifier: NCT01810250
Recruitment Status : Active, not recruiting
First Posted : March 13, 2013
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Joep Teijink, Catharina Ziekenhuis Eindhoven

Tracking Information
First Submitted Date February 12, 2013
First Posted Date March 13, 2013
Last Update Posted Date February 21, 2020
Study Start Date November 2012
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2013)
Clinical success [ Time Frame: 12 months ]
Freedom from:
  • Increase of AAA diameter > 5 mm (1 month measurement as baseline)
  • Type I&III endoleaks
  • Aneurysm rupture
  • Conversion to surgery
  • Stent graft migration (>10mm) resulting in SAE or reintervention
  • Stent graft occlusion
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 11, 2013)
Helath Related Quality of Life Scores [ Time Frame: 12 months ]
EQ-5D VAS EQ-5D index
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endurant for Challenging Anatomy: Global Experience Registry
Official Title EVAR Treatment With the Endurant Stent Graft of Challenging Anatomy in Experienced Hands, the Real World Experience
Brief Summary

The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. This study aims at creating a database that can be pooled/ compared with the ENGAGE database.

This study aims at answering two major questions:

  1. Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm?
  2. Is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

Patients with abdominal aortic aneurysms (AAAs) with challenging anatomy defined by having one or more of the following measurements:

  • Proximal necks 5 - 10mm in combination with < 60 degrees infrarenal AND < 45 degrees suprarenal angulation
  • Proximal necks 10 - 15mm in combination with 60 degrees - 75 degrees infrarenal AND < 60 degrees suprarenal angulation OR in combination with < 75 degrees infrarenal AND 45 degrees - 60 degrees suprarenal angulation
  • Proximal necks > 15mm in combination with 75 degrees - 90 degrees infrarenal AND < 75 degrees suprarenal angulation OR in combination with < 90 degrees infrarenal AND 60 degrees - 75 degrees suprarenal angulation
Condition Abdominal Aortic Aneurysms With Challenging Anatomy
Intervention Device: Endurant Stent Graft
Study Groups/Cohorts Abdominal Aortic Aneurysm (Challenging anatomy)
Endovascular aneurysm repair
Intervention: Device: Endurant Stent Graft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 31, 2018)
150
Original Estimated Enrollment
 (submitted: March 11, 2013)
350
Estimated Study Completion Date May 2023
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age ≥ 18 years or minimum age as required by local regulations
  • Indication for elective EVAR
  • Challenging AAA anatomy
  • Intention to electively implant the Endurant or Endurant II Stent Graft System©
  • Signed informed consent form

Exclusion Criteria:

  • Subjects with intolerance to contrast media
  • Chimneys or fenestrated device procedures
  • High probability of non-adherence to physician's follow-up requirements
  • Current participation in a concurrent trial that may confound study results
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01810250
Other Study ID Numbers EAGLE Registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Joep Teijink, Catharina Ziekenhuis Eindhoven
Study Sponsor Catharina Ziekenhuis Eindhoven
Collaborators Not Provided
Investigators Not Provided
PRS Account Catharina Ziekenhuis Eindhoven
Verification Date February 2020