Evaluation of the GORE® C3 Delivery System Module

W.L. Gore & Associates

Status: Completed

Conditions: Aortic Aneurysm, Abdominal

Treatments: Device: Stent graft (EXCLUDER)

Study type: Observational

Funder types: Industry

Identifiers

NCT01398332

GRT 10-12

Details and patient eligibility

About

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

Full 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.

Enrollment: 399 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

399 participants in 1 patient group

Aortic pathologies

Description:

Indication for aortic endovascular stent graft repair

Treatment:

Device: Stent graft (EXCLUDER)