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Clinical Trial Summary

In this study patients will be observed, who receive a multi-branch stent graft tailored to the patients anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V. The objective of this study is to evaluate clinical and technical success as well as safety and feasibility of the multi-branch stent graft Systems used in endovascular treatment of thoracoabdominal aortic aneurysms that cannot be treated with commercially available devices. Primary endpoint of this study is the rate of patients with stable or decreasing aneurysm size at 12 months follow-up.


Clinical Trial Description

In this study patients will be observed, who receive a multi-branch stent graft tailored to the patient´s anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with a multi-branch stent graft produced by JOTEC GmbH. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected. The period of data collection will be 36 months from the intervention for each patient. A risk based source data verification will be performed. CT angiograms will be evaluated by a CoreLab. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03295682
Study type Observational [Patient Registry]
Source JOTEC GmbH
Contact
Status Active, not recruiting
Phase
Start date September 11, 2017
Completion date March 31, 2025

See also
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