CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
Shanghai MicroPort Endovascular MedTech(Group)Co., Ltd
130 participants
Mar 8, 2024
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Plain Language Summary
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Interventions
Cratos™ Stent Graft TEVAR procedure for the treatment of aortic lesions.
Locations(1)
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NCT05874206