Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
The goal of this prospective, interventional, multicentre, single-arm performance objective study is to evaluate efficacy and safety of Cratos™ Branch Stent Graft System in treatment of lesions (dissection, IMH and PAU in descending aorta. The main question\[s\] it aims to answer are: * 30-day all-cause Mortality rate * Composite of the following events from the time of enrolment through 12-month: * Device Technical Success * Absence of: Aortic rupture, Lesion-related mortality, Disabling Stroke, Permanent paraplegia, Permanent paraparesis, New onset renal failure requiring permanent dialysis, Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the device system Participants will come for hospital office visits 1, 6, 12, 24-, 36-, 48- and 60-months post-procedure for the following, but not limited to assessments: * Physical examination * Modified Rankin scale * Tarlov scoring scale * CTA
• Presence of thoracic aortic pathology (Dissection, including IMH and ULP; and PAU) deemed to warrant surgical repair which requires proximal graft placement in Zone 2
• Age ≥18 years at time of informed consent signature
• Informed Consent Form (ICF) is signed by Subject or legal representative
• Must have appropriate proximal aortic landing zone, defined as:
‣ Landing zone inner diameters between 23-41 mm
⁃ The length of landing zone ≥15mm
⁃ Landing without heavily calcified or heavily thrombosed
⁃ Dissection Patients: Primary entry tear must be distal to LSA, and proximal extent of the proximal landing zone must not be dissected.
⁃ For patients with prior replacement of the ascending aorta and/or aortic arch by a surgical graft, there must be at least 2 cm of landing zone proximal to the most distal anastomosis site.
• Must have appropriate LSA landing zone, defined as:
‣ Inner diameters of LSA 5-14 mm
⁃ Minimum length of Left subclavian artery is 25 mm
⁃ Target branch vessel landing zone must be in native aorta that cannot be severely tortuous , aneurysmal, dissected, heavily calcified, or heavily thrombosed.
• Must have appropriate distal aortic landing zone, defined as:
‣ Aortic inner diameters between 18-44 mm
⁃ Landing zone cannot be heavily calcified, or heavily thrombosed.
⁃ For isolated PAU, outer curvature length must be ≥ 2cm proximal to the celiac artery
⁃ Landing zone in native aorta