Condition: Aortic Dissection Type B · Intramural Hematoma · Penetrating Aortic Ulcer · Sponsor: Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
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
This description comes directly from the study's public registry record.
Jing Wang · 3105283618 · jing.wang@endovastec.com
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| University Hospital Zurich | Zurich, Switzerland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05874206