NCT02104089

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3.9 years

First QC Date

April 2, 2014

Last Update Submit

January 23, 2020

Conditions

Aortic AneurysmThoracoabdominal

Keywords

Thoracoabdominal aortic aneurysmEndovascularFenestrationBranchOff-the-shelf

Outcome Measures

Primary Outcomes (1)

  • Rate of mortality and morbidity

    30 days

Study Arms (1)

Endovascular treatment

Zenith® t-Branch™ Thoracoabdominal Endovascular Graft

Device: Zenith® t-Branch™ Thoracoabdominal Endovascular Graft

Interventions

Zenith® t-Branch™ Thoracoabdominal Endovascular GraftDEVICE

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.

Endovascular treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitals

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universitäts Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

St. Franziscus Hospital-GmbH

Münster, D-48145, Germany

Location

Skaane University Hospital

Malmo, S 205 02, Sweden

Location

Related Publications (2)

  • Tsilimparis N, Bosiers M, Resch T, Torsello G, Austermann M, Rohlffs F, Coates B, Yeh C, Kolbel T. Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2023 Aug;78(2):289-298. doi: 10.1016/j.jvs.2023.03.498. Epub 2023 Apr 11.

    PMID: 37044318DERIVED

  • Bosiers M, Kolbel T, Resch T, Tsilimparis N, Torsello G, Austermann M. Early and midterm results from a postmarket observational study of Zenith t-Branch thoracoabdominal endovascular graft. J Vasc Surg. 2021 Oct;74(4):1081-1089.e3. doi: 10.1016/j.jvs.2021.01.070. Epub 2021 Mar 5.

    PMID: 33684474DERIVED

MeSH Terms

Conditions

Aortic AneurysmAortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesAortic Aneurysm, Abdominal

Study Officials

  • Giovanni B Torsello, M.D.

    St. Franziscus Hospital-GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 4, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

January 9, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

SE(1)DE(2)