NCT05126446

the Aorta Arch Stent Graft System Combined With the Endovascular Needle System in Situ Fenestration

The Aorta Arch Stent Graft System Combined With the Endovascular Needle System in Situ Fenestration Technology in the Treatment of Aortic Dissection Involving the Aortic Arch

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multi-center, single-group target value method to evaluate the safety and effectiveness of the Aorta Arch Stent Graft System combined with the Endovascular Needle System in situ fenestration technology in the treatment of aortic dissection involving the aortic arch

Detailed description

1. Clinical trials using prospective, multi-center, single-group target value design; 2. 120 subjects with aortic dissection requiring partial arch reconstruction will be enrolled in more than 30 centers in China, and they will meet the test enrollment requirements. 3. CTA examination was performed at baseline, 30 days, 6 months, 12 months, 36 months, and 60 months after surgery to determine the pathological status and the status of postoperative aortic and branch revascularization

Conditions

• Aortic Dissection

Interventions

Type	Name	Description
DEVICE	the Aorta Arch Stent Graft System combined with the Endovascular Needle System	Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with device

Timeline

• Start date: 2021-07-25
• Primary completion: 2027-10-30
• Completion: 2028-03-30
• First posted: 2021-11-19
• Last updated: 2024-07-23

Locations

1 site across 1 country: China