Key result
This is a study protocol for a prospective, multicenter, single-arm registry evaluating the safety and efficacy of a novel in situ fenestration system in TEVAR for aortic arch pathologies.
Why the study?
Thoracic endovascular aortic repair has become the mainstream therapy for aortic arch pathologies, but the safety and effectiveness of a newly self-developed in situ fenestration system required evaluation.
Is the self-developed in situ fenestration system safe and effective during TEVAR for patients with aortic arch pathologies?
Observational
Yes
Is the self-developed in situ fenestration system safe and effective during TEVAR for patients with aortic arch pathologies?
This protocol outlines a prospective, multicenter, single-arm study to evaluate the safety and efficacy of a novel in situ fenestration system during TEVAR for aortic arch pathologies over a 5-year follow-up.
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 evaluate this self-developed ISF system. ETHICS AND DISSEMINATION: The study is a registry. We have registered the study on the Chinese Clinical Trial Registry website (http://www.chictr.org.cn/). This study has been approved by the Ethics Committee of Zhongshan Hospital Fudan University (B2020-371) and individual consents will be signed at the time of enrolment. We anticipate that this self-developed ISF system will result in favourable social and economic benefits. Findings will be disseminated in peer-reviewed journals to provide reference for future clinical practice. TRIAL REGISTRATION NUMBER: ChiCTR1900026696.
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Sun et al. (2021) conducted an observational in Aortic arch pathologies (AAP). TEVAR with in situ fenestration (ISF) system was evaluated on Safety and efficacy endpoints. This is a study protocol for a prospective, multicenter, single-arm registry evaluating the safety and efficacy of a novel in situ fenestration system in TEVAR for aortic arch pathologies.
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