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CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions

Intramural Hematoma Clinical Trial

Official title:
Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05874206
Study type Interventional
Source Shanghai MicroPort Endovascular MedTech(Group)Co., Ltd
Contact Jing Wang
Phone +13105283618
Email jing.wang@endovastec.com
Status Not yet recruiting
Phase N/A
Start date March 2024
Completion date December 2031
View Details
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