Clinical Trials Logo
  1. Home
  2. Aortic Aneurysm
  3. NCT02104089
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT04149600 - Identification of Genetic Causes of Calcific Aortic Valve Disease
Enrolling by invitation NCT04035356 - HAART Annuloplasty Device Valve Repair Registry
Recruiting NCT02729064 - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose Phase 1
Completed NCT02467062 - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease. N/A
Completed NCT02283307 - Dual Energy CT Urography With Reduced Iodinated Contrast N/A
Completed NCT01678261 - X-chromosome Inactivation, Epigenetics and the Transcriptome N/A
Terminated NCT01055275 - Cook Iliac Branch Graft Post-market Registry N/A
Completed NCT00615888 - Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair N/A
Completed NCT03510793 - Microcirculation and Anesthesia in Vascular Surgery
Completed NCT03207568 - RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU) N/A
Recruiting NCT05073991 - Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
Not yet recruiting NCT01918982 - Circulating Endothelial Progenitor Cells and Aortic Aneurysm N/A
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Not yet recruiting NCT01918969 - Reference Values of Circulating Endothelial Progenitor Cells N/A
Completed NCT01256372 - An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery Phase 2
Recruiting NCT00661518 - PET/CT Imaging of Aneurysm Wall Inflammation N/A
Completed NCT00094575 - Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA) Phase 4
Recruiting NCT04471909 - NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness N/A
Recruiting NCT05603520 - Phenotyping Heterogeneity and Regionality of the Aorta
Completed NCT03727542 - Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels N/A