Evaluation for the safety and effectiveness of the in situ fenestration system in TEVAR for aortic arch pathologies: protocol for a prospective, multicentre and single-arm study.

ABSTRACT:

Introduction

Thoracic endovascular aortic repair (TEVAR) has gradually become the mainstream therapy for aortic arch pathologies (AAP). Our centre developed the in situ fenestration (ISF) system according to years of clinical experience and technological innovation. This study aims to evaluate the safety and effectiveness of the innovative, self-developed ISF system in TEVAR for AAP.

Methods and analysis

The study is a prospective, multicentre and single-arm study. Patients diagnosed with AAPs in five centres on 1 January 2021 will be recruited and general TEVAR with ISF system will be performed. Clinical information and CT angiography images will be collected and recorded. Patients will be followed up for 5 years. Safety and efficacy endpoints are planned to be reported to

SUBMITTER: Sun X 

PROVIDER: S-EPMC7903081 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature