Evaluation of the GORE® C3 Delivery System Module

Completed

• Conditions: Aortic Aneurysm, Abdominal

• Registration Number: NCT01398332
• Lead Sponsor: W.L.Gore & Associates

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Status Verified: 2024-07
• Primary Completion: 2024-07
• Study Completion: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 399

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Klinikum Nürnberg-Süd; 🇩🇪 Nurnberg, Germany