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Completed

NCT Number: NCT01398332

Evaluation of the GORE® C3 Delivery System Module

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

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Key information

Conditions

Aortic Aneurysm, Abdominal Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Nürnberg-Süd

Nuremberg, 90471, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Minimum age required by local regulations (as applicable)
  • 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)

Treatment and study plan

Stent graft (EXCLUDER)

Device

Endovascular repair

Other names: EXCLUDER

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

Global Registry for Endovascular Aortic Treatment (GREAT)

Important dates

Study start
2011
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2011
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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