Protocol for GUo's renovisceral Artery reconstruction-1: a prospective, multicentre, single-arm clinical trial to evaluate the safety and efficacy of a multibRANched sTEnt graft systEm for thoracoabdominal aortic aneurysm (GUARANTEE study).

Abstract

INTRODUCTION:

The multibranched off-the-shelf stent graft is a promising treatment option for thoracoabdominal aortic aneurysm (TAAA). A commercially available, multibranched, off-the-shelf endograft called the t-Branch stent graft has demonstrated favourable midterm outcomes. Another two investigational off-the-shelf endografts, the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis and E-nside multibranch stent graft system, are still being developed. However, these three endografts have an unsatisfactory anatomic feasibility rate in patients with TAAA. Based on the concept of Guo's renovisceral artery reconstruction-1, a novel, multibranched, off-the-shelf endograft with different configurations has been developed.

METHODS AND ANALYSIS:

This prospective, multicentre, single-arm, cohort study will enrol 73 patients with TAAA. Preoperative and postoperative clinical data, as well as CT angiography images at each follow-up timepoint, will be analysed to evaluate the safety and efficacy of this novel, multibranched, off-the-shelf endograft for the treatment of TAAA. The primary safety end point is the major adverse event rate within 30 days after index endovascular aortic repair, including all-cause death, hepatic failure, bowel necrosis, renal failure, stroke, permanent paraplegia, cardiac infarction and respiratory failure. The primary efficacy end point is the successful treatment rate within 12 months after procedure, which is a composite of immediate technical success and no secondary surgical intervention related to TAAA within 12 months after the procedure.

ETHICS AND DISSEMINATION:

The protocol has been reviewed and approved by the ethics committee of Chinese PLA General Hospital (reference number: 2021-NO.-007) and each participating hospital. The findings of this study will be disseminated through conference presentations, peer-reviewed journal publications and social media.

TRIAL REGISTRATION NUMBER:

NCT05054985.

• Authors: Yangyang Ge, Hongpeng Zhang, Dan Rong, Feng Liu, Xin Jia, Jiang Xiong, Xiaohui Ma, Lijun Wang, Tingting Fan, Wei Guo
• Journal: BMJ open (BMJ Open) Vol. 12 Issue 3 Pg. e059401 (03 23 2022) ISSN: 2044-6055 [Electronic] England
• PMID: 35321900 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Topics

• Aortic Aneurysm, Thoracic (diagnostic imaging, surgery)
• Arteries
• Blood Vessel Prosthesis
• Blood Vessel Prosthesis Implantation
• Cohort Studies
• Endovascular Procedures (adverse effects)
• Humans
• Multicenter Studies as Topic
• Postoperative Complications (etiology)
• Prospective Studies
• Prosthesis Design
• Stents (adverse effects)