NCT06478576

Study on Multibranched Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysm

GUo's Renovisceral Artery Reconstruction-2: a Prospective,Single Center,Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a multibRANched sTEnt Graft systEm for Thoracoabdominal Aortic Aneurysm

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)

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

• Thoracoabdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	multibranched stent graft system	To evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)

Timeline

• Start date: 2023-06-01
• Primary completion: 2028-05-30
• Completion: 2028-05-30
• First posted: 2024-06-27
• Last updated: 2024-07-12

Locations

1 site across 1 country: China