NCT03965364

China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION)

A Multicenter, Open Label, Prospective, Post-Market Study of the INCRAFT AAA Stent Graft in Subjects With Abdominal Aortic Aneurysms

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate.

Detailed description

INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate. Subjects will be enrolled and followed at 1 month and 1 year post-procedure.

Conditions

• Abdominal Aortic Aneurysms

Interventions

Type	Name	Description
DEVICE	INCRAFT	Device: Endovascular abdominal aortic aneurysm repair Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System.

Timeline

• Start date: 2019-08-31
• Primary completion: 2020-08-31
• Completion: 2021-12-31
• First posted: 2019-05-29
• Last updated: 2021-02-26

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study