NCT06915545

Study on the Aortic Arch Single Branch Stent Graft System

Study on the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

Detailed description

The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee

Conditions

• Aortic Dissection

Interventions

Type	Name	Description
DEVICE	Aortic Arch Single Branch Covered Stent System	to Evaluate the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

Timeline

• Start date: 2025-04-30
• Primary completion: 2027-04-30
• Completion: 2031-06-30
• First posted: 2025-04-08
• Last updated: 2025-06-11

Locations

1 site across 1 country: China