Post-market Observational Study Zenith® t-Branch™

January 23, 2020 updated by: Cook Group Incorporated

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Both retrospective and prospective patients will be enrolled

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, D-20246
        • Universitäts Krankenhaus Eppendorf
      • Münster, Germany, D-48145
        • St. Franziscus Hospital-GmbH
  • Sweden
      • Malmö, Sweden, S 205 02
        • Skaane University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endovascular treatment
Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of mortality and morbidity
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Giovanni B Torsello, M.D., St. Franziscus Hospital-GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 9, 2020

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-017 (Dana-Farber Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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