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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
  Purpose

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


Condition Intervention
Aortic Aneurysm, Abdominal
Device: Endurant Stent Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endurant Stent Graft Natural Selection Global Postmarket Registry

Resource links provided by NLM:


Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • Treatment success Treatment Success [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1200
Study Start Date: March 2009
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Device: Endurant Stent Graft
Endurant Stent Graft implantation
Other Name: EVAR

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Additional 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
Study First Received: March 25, 2009
Last Updated: July 10, 2014
Health Authority: Australia: Human Research Ethics Committee
Spain: Ethics Committee
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
Israel: Ministry of Health
Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on November 27, 2014