NCT06660927

The Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System

A Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (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 Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA).

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

• Common Iliac Artery Aneurysm

Interventions

Type	Name	Description
DEVICE	liac Bifurcation Stent Graft System	to evaluate the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA)

Timeline

• Start date: 2021-11-30
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2024-10-28
• Last updated: 2024-10-28

Locations

1 site across 1 country: China