NCT05874206

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Aortic Dissection Type B
• Intramural Hematoma
• Penetrating Aortic Ulcer

Interventions

Type	Name	Description
DEVICE	Cratos™ Stent Graft	Cratos™ Stent Graft TEVAR procedure for the treatment of aortic lesions.

Timeline

• Start date: 2024-03-08
• Primary completion: 2026-12-01
• Completion: 2031-12-01
• First posted: 2023-05-24
• Last updated: 2025-02-26

Locations

1 site across 1 country: Switzerland