AUTHOR=Gao Jiang-Ping , Zhang Hong-Peng , Jia Xin , Xiong Jiang , Ma Xiao-Hui , Wang Li-Jun , Zhang Min-Hong , Xu Yong-Le , Guo Wei 

TITLE=A prospective, multicenter, single-arm clinical trial cohort to evaluate the safety and effectiveness of a novel stent graft system (WeFlow-JAAA) for the treatment of juxtarenal abdominal aortic aneurysm: A study protocol

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=Volume 9 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.1013834

DOI=10.3389/fcvm.2022.1013834

ISSN=2297-055X

ABSTRACT=Introduction 
Juxtarenal abdominal aortic aneurysms are challenging to cure by traditional endovascular aortic repair (EVAR). Due to the inherent disadvantages of the customized fenestrated and/or branched aortic endografts (such as delayed cycles with a risk of aneurysm rupture, unavailable in emergency or confine operations), several off-the-shelf devices have been developed for the treatment of JRAAA. However, these devices being used in clinical trials have been proven to have a nonnegligible risk of reintervention and inadequate anatomic applicability. We have developed a new off-the-shelf aortic endograft system (WeFlow-JAAA) with a mixed design of inner branches and modified fenestrations. The purpose of this cohort study is to assess the safety and effectiveness of the innovative aortic endograft system.
Methods and analysis
This is a prospective, multicentre, single-armed clinical trial cohort study. The enrolment will take place in 29 centres in China, and 106 adult patients with JRAAA will be enrolled in total. Clinical information and CT angiography images will be collected and recorded. Patients will be followed up for 5 years. The primary safety endpoint is the rate of no major adverse event within 30 days after index endovascular aortic repair. The primary efficacy endpoint is the rate of immediate technical success and no JRAAA-related reintervention within 12 months after the procedure.
Ethics and dissemination
This protocol has been reviewed and approved by the ethics committee of Chinese PLA General Hospital (reference number: 2021-25-01) and each participating hospital. The results will be published in peer-reviewed journals and presented at relevant conferences. 
Trial registration number
NCT05179967 
Registered name
Guo's visceRal artEries Reconstruction: The Prospective, Multiple Center, Objective Performance Criteria Clinical Trial About the sAfeTy and Efficacy of WeFlow-JAAATM Stent Graft System (GREAT Study)