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
Landing zone inner diameters between 23-41 mm
Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
Previous endovascular repair of the ascending aorta
Infected aorta, active systemic infection
Surgery within 30 days prior to enrolment with the exception of placement of vascular conduit for access .
Single group
Cratos™ Stent Graft
DeviceCratos™ Stent Graft TEVAR procedure for the treatment of aortic lesions.
Mortality
All-cause mortality
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Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Lead sponsor
Qmed Consulting A/S
Collaborator
