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Post-market Observational Study Zenith® t-Branch™

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104089
Recruitment Status : Active, not recruiting
First Posted : April 4, 2014
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Aortic Aneurysm Thoracoabdominal Device: Zenith® t-Branch™ Thoracoabdominal Endovascular Graft

Detailed Description:
Both retrospective and prospective patients will be enrolled

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Post-market Observational Study Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
Study Start Date : January 2014
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Rate of mortality and morbidity [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitals
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104089


Locations
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Germany
Universitäts Krankenhaus Eppendorf
Hamburg, Germany, D-20246
St. Franziscus Hospital-GmbH
Münster, Germany, D-48145
Sweden
Skaane University Hospital
Malmö, Sweden, S 205 02
Sponsors and Collaborators
Cook Group Incorporated
Investigators
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Principal Investigator: Giovanni B Torsello, M.D. St. Franziscus Hospital-GmbH

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Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT02104089     History of Changes
Other Study ID Numbers: 12-017
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Keywords provided by Cook Group Incorporated:
Thoracoabdominal aortic aneurysm
Endovascular
Fenestration
Branch
Off-the-shelf
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases