NCT05054985

Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.

Guo's Renovisceral Artery Reconstruction-1: a Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a Multi-branched Stent Graft System for Thoracoabdominal Aortic Aneurysm (GUARANTEE Study)

• 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

Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.

Detailed description

The study is mainly for patients with thoracoabdominal aortic aneurysms, and all subjects who signed the informed consent and passed the screening will be enrolled. Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system. Patients will be followed up at discharge, 1 month, 6 months, 12 months after the implantation.

Conditions

• Thoracoabdominal Aortic Aneurysms

Interventions

Type	Name	Description
DEVICE	Multi-Branched Thoracoabdominal Stent Graft System	Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system .

Timeline

• Start date: 2021-11-12
• Primary completion: 2025-12-31
• Completion: 2028-12-31
• First posted: 2021-09-23
• Last updated: 2025-06-22

Locations

1 site across 1 country: China