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NCT02104089 Clinical Trial

Post-market Observational Study Zenith® t-Branch™

Aortic Aneurysm Clinical Trial

Official title:
Post-market Observational Study Zenith® t-Branch™ Thoracoabdominal Endovascular Graft

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02104089
Other study ID # 12-017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date January 9, 2020

Study information
Verified date January 2020
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Both retrospective and prospective patients will be enrolled

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date January 9, 2020
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guide the study device(s) into place in the aorta.

Locations
Country Name City State
Germany Universitäts Krankenhaus Eppendorf Hamburg
Germany St. Franziscus Hospital-GmbH Münster
Sweden Skaane University Hospital Malmö

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Countries where clinical trial is conducted

Germany,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of mortality and morbidity 30 days
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