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NCT01398332 Clinical Trial

Evaluation of the GORE® C3 Delivery System Module

Aortic Aneurysm, Abdominal Clinical Trial

Official title:
Global Registry for Endovascular Aortic Treatment (GREAT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01398332
Other study ID # GRT 10-12
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2011
Est. completion date June 2024

Study information
Verified date May 2024
Source W.L.Gore & Associates
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 399
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Stent graft (EXCLUDER)
Endovascular repair

Locations
Country Name City State
Germany Klinikum Nürnberg-Süd Nurnberg

Sponsors (1)
Lead Sponsor Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Up to 10 Years
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