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 study evaluates the Cratos Branch Stent Graft System — a specialized endovascular device — for treating diseases of the descending thoracic aorta, including dissections and ulcers that require placement in a specific landing zone involving the left subclavian artery (the artery supplying the left arm). Thoracic aortic diseases can be life-threatening, and traditional open surgery carries high risk. The Cratos device is designed to allow minimally invasive repair while maintaining blood flow to critical branch vessels like the left subclavian artery. Adult patients aged 18 or older with thoracic aortic pathology deemed to need surgical repair, appropriate aortic anatomy confirmed by CT imaging, and adequate vessel dimensions in the treatment zone are eligible. Patients with recent stroke or heart attack, active infection, connective tissue disorders (like Marfan syndrome), severe kidney disease, or pregnancy are excluded. Participants will undergo the endovascular procedure with the Cratos device and be followed for clinical outcomes including procedural success, complications, and aortic health over time. This study matters because it could validate a less invasive option for treating complex thoracic aortic disease, improving survival and recovery compared to open surgery for patients who may not tolerate it well.

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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