Evaluation of the GORE® C3 Delivery System Module

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

399 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2024-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Aortic Aneurysm, Abdominal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aortic pathologies

Indication for aortic endovascular stent graft repair

Stent graft (EXCLUDER)

Intervention Type DEVICE

Endovascular repair

Interventions

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Stent graft (EXCLUDER)

Endovascular repair

Intervention Type DEVICE

Other Intervention Names

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EXCLUDER

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No