RecruitingNot ApplicableNCT05874206

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


Sponsor

Shanghai MicroPort Endovascular MedTech(Group)Co., Ltd

Enrollment

130 participants

Start Date

Mar 8, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Cratos™ Stent Graft for people with aortic dissection type b, intramural hematoma, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECratos™ Stent Graft

Cratos™ Stent Graft TEVAR procedure for the treatment of aortic lesions.


Locations(1)

University Hospital Zurich

Zurich, Switzerland

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NCT05874206


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