Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00870051
First received: March 25, 2009
Last updated: July 10, 2014
Last verified: July 2014

March 25, 2009
July 10, 2014
March 2009
January 2017   (final data collection date for primary outcome measure)
Treatment success Treatment Success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The proportion of subjects who experience a treatment success at 12 months post-implantation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00870051 on ClinicalTrials.gov Archive Site
  • Stent graft migration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stent graft patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stent graft endoleaks [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: No ]
  • Secondary procedures to correct Type I and III endoleaks [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Secondary endovascular procedure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Adverse device effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Technical Observations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Aneurysm-related mortality [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: No ]
  • MAE [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Health Related Quality of Life Scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects who are free from stent graft migration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects who are free from stent graft patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects who are free from stent graft endoleaks [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • The proportion of subjects who are free from secondary procedures to correct Type I and III endoleaks [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects who are free from secondary endovascular procedure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects who are free from adverse device effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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, 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
January 2017
January 2017   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00870051
P#888
No
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
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP