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

Abdominal Aortic Aneurysms Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03965364
Study type Observational [Patient Registry]
Source Cordis Corporation
Contact
Status Withdrawn
Phase
Start date August 31, 2019
Completion date December 31, 2021
View Details
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