NCT06520774

Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases

A Prospective, Multicenter, Single-Group Target-Value Clinical Trial: Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (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 the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases

Detailed description

The physician must strictly adhere to the clinical study protocol and shall not deviate from or substantially alter it. However, in cases of emergency where there is an immediate risk to the subjects that must be eliminated immediately, a report may be submitted in written form afterward. During the study, any amendments to the clinical study protocol, informed consent documents, requests for deviation, and the resumption of a suspended clinical study must receive written approval from the Ethics Committee.

Conditions

• Aortic Arch Aneurysm
• Penetrating Aortic Ulcer

Interventions

Type	Name	Description
DEVICE	Concave Supra-arch Branched Stent-Graft System	To evaluate the efficacy and safety of Concave Supra-arch Branched Stent-Graft System for endovascular treatment of Aortic Arch Diseases

Timeline

• Start date: 2024-05-30
• Primary completion: 2027-07-30
• Completion: 2031-06-30
• First posted: 2024-07-25
• Last updated: 2025-07-28

Locations

17 sites across 2 countries: China, Germany