Outcomes of endovascular aortic arch repair with an off-the-shelf modular inner branched stent-graft: an IDEAL 2a prospective multicentre trial
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: 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. METHOD: 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. RESULTS: 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. CONCLUSION: 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.
Source: British journal of surgery
DOI: 10.1093/bjs/znaf279
Institutions: Nankai University, Chinese PLA General Hospital, First Affiliated Hospital Zhejiang University, Zhejiang University, Hebei Medical University, First Affiliated Hospital of Hebei Medical University, Nanjing First Hospital, Xiamen University, Shandong Provincial Hospital, First People's Hospital of Yunnan Province, The First Hospital of Kunming, Central South University, Xiangya Hospital Central South University, First Affiliated Hospital of Zhengzhou University, Shanghai Medical College of Fudan University, Fudan University, Zhongshan Hospital, Peking University People's Hospital, Affiliated Hospital of Qingdao University, The First Affiliated Hospital, Sun Yat-sen University, Tianjin Medical University General Hospital, Tianjin Medical University, Air Force Medical University, West China Hospital of Sichuan University, Second Affiliated Hospital of Zhejiang University
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,007
Awards: G1606887372, G6234255455, G8951458780
OpenAlex ID: W7121365103