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Evaluation of the GORE® C3 Delivery System Module

Global Registry for Endovascular Aortic Treatment (GREAT)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01398332
Enrollment
399
Registered
2011-07-20
Start date
2011-01-31
Completion date
2024-07-31
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Abdominal

Brief summary

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

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.

Interventions

DEVICEStent graft (EXCLUDER)

Endovascular repair

Sponsors

W.L.Gore & Associates
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime 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.Up to 10 Years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026