CRATOS - 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

NCT Number	NCT05874206
Lead Sponsor	Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd Collaborators: Qmed Consulting A/S
Conditions	Aortic Dissection Type B, Intramural Hematoma, Penetrating Aortic Ulcer
Enrollment	130 participants
Start Date	2024-03-08
Primary Completion	2026-12 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2025-02-26