Evaluation of the GORE® C3 Delivery System Module

July 30, 2024 updated by: W.L.Gore & Associates

Global Registry for Endovascular Aortic Treatment (GREAT)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

399

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Nurnberg, Germany, 90471
        • Klinikum Nürnberg-Süd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who undergo endovascular treatment for aortic pathologies with the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aortic pathologies
Indication for aortic endovascular stent graft repair
Device: Stent graft (EXCLUDER)
Endovascular repair
Other Names:
  • EXCLUDER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Investigators

  • Principal Investigator: Eric Verhoeven, MD, Klinikum Nürnberg-Süd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimated)

July 20, 2011

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRT 10-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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