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CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
Sponsor: Shanghai MicroPort Endovascular MedTech(Group)Co., Ltd
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
Official title: Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2024-03-08
Completion Date
2031-12
Last Updated
2025-02-26
Healthy Volunteers
Yes
Interventions
Cratos™ Stent Graft
Cratos™ Stent Graft TEVAR procedure for the treatment of aortic lesions.
Locations (1)
University Hospital Zurich
Zurich, Switzerland