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RECRUITING
NCT05874206
NA

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

Sponsor: Shanghai MicroPort Endovascular MedTech(Group)Co., Ltd

View on ClinicalTrials.gov

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

DEVICE

Cratos™ Stent Graft

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

Locations (1)

University Hospital Zurich

Zurich, Switzerland