NCT05430672

Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection

A Prospective, Multicenter, Objective Performance Criteria-Controlled Study for National Medical Products Administration Approval Of The Thoracic Aortic Stent Graft System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Zhejiang Zylox Medical Device Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter and single-arm trail to study the safety and efficacy of the thoracic aortic stent graft system that specially designed for treating aortic dissection.

Detailed description

This trail is conducted in several centers all around China. In about 18 months, 120 subjects with aortic dissection will be recruited, all of which receive endovascular treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ). The subjects will be followed up in 30 days/ 6 months/ 12 months/ 2-5 years.

Conditions

• Aortic Dissection

Interventions

Type	Name	Description
DEVICE	The Thoracic Aortic Stent Graft System (Zylox-Tonbridge Medical Technology Co., Ltd. )	This is a objective performance criteria-controlled study, all subjects meet the criteria will receive the same treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ).

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-08-01
• Completion: 2024-08-01
• First posted: 2022-06-24
• Last updated: 2022-06-24

Locations

14 sites across 1 country: China