Evaluation of Cratos Branch Stent Graft System in Treatment of Descending Aorta lesions

Type B aortic dissection means there is tear in the aorta. Because of this dissection, blood flows through the tear and causes different layers in the aorta to separate. In some cases, there is a presence of intramural haematoma (IMH) or penetrating aortic ulcer (PAU). IMH is a swelling caused by accumulated blood within the layers in the aorta. PAU is a hardening of the arteries that form an ulcer penetrating the aortic wall. The blood flow will be diverted to the tissue layers and can cause the aorta to rupture. This is a life-threatening condition that needs urgent surgical treatment. Endovascular stent-graft repair (EVAR) is a treatment where a stent-graft is used to repair the aorta from within. The stent-graft is a synthetic fabric tube supported by metal wires. It is inserted to the body through a small incision in the groin. A catheter, with the stent-graft attached, is then delivered into the aorta under x-ray guidance. Once the stent-graft is in place it opens, covers and provides reinforcement to the weak area in the aorta. When implanting the stent-graft, there is often a need to restore potentially restricted or blocked blood flow in the left subclavian artery (LSA). This artery starts from the aortic arch and moves oxygen-rich blood from the heart to the upper body. It is a major supplier of blood to your neck, head, and arms. During revascularisation of the LSA there is a risk of stroke or bleeding. CratosTM Thoracic Branch Stent Graft System allows both the EVAR and LSA revascularisations to be performed in a single procedure in patients diagnosed with a Type B aortic dissection; IMH or PAU.The objective of the study is to evaluate the efficacy and safety of CratosTM Branch Stent Graft System in treating lesions in descending aorta.