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Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)

Abdominal Aortic Aneurysm Clinical Trial

Official title:
Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)

Clinical Trial Summary

The sudy purpose is to investigate efficacy and safety of percutaneous endovascular aortic aneurysm repair using INCRAFT stent graft for Korean patients with abdominal aortic aneurysm. This study is designed as an investigator-initiated, multi-center, single-arm, prospective registry study. A total of 100 patients who meet all inclusion criteria, but none of exclusion criteria will be enrolled after the implantation of INCRAFT stent graft. The primary efficacy outcome is technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. The primary safety outcome is major vascular complications at 30 days including. The study subjects will be followed for 12 months.

Clinical Trial Description

Prospective single-arm multicenter registry ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03952780
Study type Observational
Source Yonsei University
Contact
Status Completed
Phase
Start date September 2, 2019
Completion date September 20, 2023
View Details
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