Protocol for Guos aortIc Arch recoNstrucTion: a prospective, multicentre and single-arm study to evaluate the safety and efficacy of the WeFlow-Arch modular inner branch stent-graft system for aortic arch lesions (GIANT study)

This study aims to evaluate the safety and efficacy of the novel modular branch stent-graft system in patients with aortic arch lesions who are unsuitable for open aortic arch replacement. Methods and analysis This prospective, multicentre, single-arm, clinical trial will enrol 80 patients with aortic arch lesions requiring intervention, namely, true aortic arch aneurysms, pseudo-aortic arch aneurysms and penetrating ulcers involving the aortic arch. Clinical information and CT angiography (CTA) images will be collected and analysed to investigate the safety and efficacy of the novel modular branch stent-graft system. Patients will be followed up for 5 years. The primary outcome will be all-cause mortality and severe stroke within 12 months after the procedure. In addition, this trial will evaluate mid-term to long-term clinical and imaging outcomes through the annual clinical and CTA follow-up for 2–5 years postoperatively. Ethics and dissemination We have registered the study on a registry website (https://clinicaltrials.gov/ct2/home). The study findings will be disseminated through peer-reviewed journals, physician newsletters, conferences and the mass media. Trial registration number NCT04765592.
Source: BMJ Open - Category: General Medicine Authors: Tags: Open access, Surgery Source Type: research