Post-market Observational Study Zenith® t-Branch™

Completed

• Conditions: Aortic Aneurysm; Thoracoabdominal
• Interventions: Device: Zenith® t-Branch™ Thoracoabdominal Endovascular Graft

• Registration Number: NCT02104089
• Lead Sponsor: Cook Group Incorporated

Brief Summary

The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of thoracoabdominal aortic aneurysms in routine care.

Detailed Description

Both retrospective and prospective patients will be enrolled

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-04
• Primary Completion: 2017-12
• Status Verified: 2020-01
• Study Completion: 2020-01-09
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Treated with the off-the-shelf Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
• Signed informed consent

Exclusion Criteria

• Inability or refusal to give informed consent by the patient or a legally authorized representative

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endovascular treatment	Zenith® t-Branch™ Thoracoabdominal Endovascular Graft	Zenith® t-Branch™ Thoracoabdominal Endovascular Graft

Primary Outcome Measures

Name	Time	Method
Rate of mortality and morbidity	30 days

Trial Locations

Locations (3)

Universitäts Krankenhaus Eppendorf; 🇩🇪 Hamburg, Germany

St. Franziscus Hospital-GmbH; 🇩🇪 Münster, Germany

Skaane University Hospital; 🇸🇪 Malmö, Sweden