Overview

This trial is active, not recruiting.

Condition aortic aneurysm, abdominal
Treatment stent graft (excluder)
Sponsor W.L.Gore & Associates
Start date January 2011
End date November 2012
Trial size 400 participants
Trial identifier NCT01398332, GRT 10-12

Summary

This is an observational Registry designed to obtain early data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Indication for aortic endovascular stent graft repair
stent graft (excluder) EXCLUDER
Endovascular repair

Primary Outcomes

Measure
Evaluate procedural outcomes for the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System when used in accordance with the standard medical practice at each participating hospital.
time frame: Up to 10 Years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 1. Minimum age required by local regulations (as applicable) 2. Indication for aortic endovascular stent graft repair as determined by the treating physician (refer to current Instructions for Use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System)

Additional Information

Official title Global Registry for Endovascular Aortic Treatment(GREAT)
Principal investigator Eric Verhoeven, MD
Description This is a retrospective and prospective observational cohort Registry designed to obtain data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System. Patient and device performance outcomes will be collected during treatment and throughout all post-treatment visits, including follow-up extending up to 10 years.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by W.L.Gore & Associates.