# Outcomes of endovascular aortic arch repair with an off-the-shelf modular inner branched stent-graft: an IDEAL 2a prospective multicentre trial

## TL;DR

This study evaluates a new modular stent-graft for treating aortic arch disease, showing it is safe and effective compared to other methods.

## Contribution

The study introduces a non-customized modular aortic arch stent-graft and reports outcomes from the largest cohort to date.

## Key findings

- Technical success rate was 100% with a 3% 30-day mortality rate.
- Stroke rate was 9% and overall survival rates were 91%, 86%, and 81% at 12, 24, and 36 months.
- Endoleaks occurred in 10 patients but none required reintervention.

## Abstract

Aortic arch pathologies are complex to treat. Alternatives include open surgery, hybrid surgery (endovascular aortic stent-grafting and open surgical debranching procedures) and total endovascular solutions with branched stent-grafts. Branched stent-grafts are the mainstream approach for endovascular repair, but they are primarily available only as dedicated custom-made devices. The aim of this study was to evaluate the safety and effectiveness of a non-customized modular aortic arch stent-graft.

This trial was led by the Chinese PLA General Hospital and 16 additional aortic centres in China. All included patients were treated with a non-customized modular inner branched stent-graft (Endonom Medtech, Hangzhou, China). The study endpoints were 30-day death and stroke, technical success, clinical success, early and late complications, reintervention, and death during follow-up. Follow-up via clinical examination and CT angiography scan were scheduled post surgery at 1, 6, and 12 months, and annually thereafter.

From June 2021 to December 2024, a total of 88 patients were enrolled in this study. Technical success rate was 100%. The mean follow-up was 28.6 ± 11.7 months. The overall 30-day mortality rate was 3%, and the 30-day stroke rate was 9%. Overall survival was 91% ± 3%, 86% ± 4%, and 81% ± 4% at 12, 24, and 36 months respectively. A total of 10 patients developed endoleaks, none of which required reintervention.

Modular branched stent-graft repair for aortic arch disease is feasible and with comparative rates of safety with custom made branched endovascular stent-grafts, hybrid techniques and open surgery. Long-term comparative effectiveness studies are required to establish whether it is superior to alternative interventions.

This study reported a novel modular aortic arch stent graft and included the largest cohort to date, demonstrating significantly lower death compared to open surgery, comparable stroke rates to current arch stent grafts, and lower reintervention rates than current arch stent grafts.