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.
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 Type
OBSERVATIONAL
Enrollment
47
Endovascular treatment of patients with thoracoabdominal aneurysm using a multibranch stent graft tailored to the patient´s anatomy in combination with peripheral covered stents to bridge the visceral arteries
Uniklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Rate of patients with stable or decreasing aneurysm size at 12 months follow-up (measured by CoreLab)
Decreasing size: \>/= 5mm Increasing size: \</= 5mm compared to first post-operative CT angiogram
Time frame: 12 months follow-up
Rate of all cause mortality
Time frame: intra-op, post-op until 36 months follow-up
Rate of patients with aneurysm rupture
Time frame: post-op until 36 months follow-up
Rate of patients with main adverse events (product-related, procedure-related, aneurysm-related)
Time frame: post-op until 36 months follow-up
Rate of interventions in peri-operative periods (all related interventions until index procedure)
Time frame: intra-op
Rate of reinterventions
Time frame: post-op until 36 months follow-up
Rate of patients with endoleaks type Ia, Ib, II, III, IV, V and of unknown origin
Time frame: post-op until 36 months follow-up
Rate of patients with multi-branch stent graft migration
Time frame: post-op until 36 months follow-up
Rate of patients with loss of device integrity
Time frame: post-op until 36 months follow-up
Rate of patients with primary / secondary patency of branch vessels
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Time frame: post-op until 36 months follow-up
Rate of patients with stent graft infection
Time frame: post-op until 36 months follow-up
Rate of patients with primary / secondary technical success
Time frame: post-op until 36 months follow-up
Rate of patients with primary / secondary clinical success
Time frame: post-op until 36 months follow-up
Rate of patients with removal or failure to implant the multi-branch stent graft
Time frame: intra-op, post-op until 36 months follow-up