Outcomes of endovascular aortic arch repair with an off-the-shelf modular inner branched stent-graft: an IDEAL 2a prospective multicentre trial
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Le résumé fourni par la source
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.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Outcomes of endovascular aortic arch repair with an off-the-shelf modular inner branched stent-graft: an IDEAL 2a prospective multicentre trial
- Date Crossref
- 24/12/2025
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Nankai University pays non établi dans la noticeUniversité ou école supérieure
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Chinese PLA General Hospital Department of Vascular and Endovascular Surgery pays non établi dans la noticeÉtablissement de santé
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First Affiliated Hospital Zhejiang University pays non établi dans la noticeÉtablissement de santé
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Nanjing Traditional Chinese Medicine Hospital pays non établi dans la noticeÉtablissement de santé
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First Affiliated Hospital of Hebei Medical University pays non établi dans la noticeÉtablissement de santé
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Nanjing Medical University pays non établi dans la noticeUniversité ou école supérieure
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Xiamen University Department of Vascular Surgery pays non établi dans la noticeUniversité ou école supérieure
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First Affiliated Hospital of Xiamen University pays non établi dans la noticeÉtablissement de santé
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Zhongshan Hospital of Xiamen University pays non établi dans la noticeÉtablissement de santé
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Xiamen Chang Gung Hospital pays non établi dans la noticeÉtablissement de santé
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Shandong Provincial Hospital Department of Vascular Surgery pays non établi dans la noticeÉtablissement de santé
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First People's Hospital of Yunnan Province Department of Vascular Surgery pays non établi dans la noticeÉtablissement de santé
Nankai University, Department of Vascular and Endovascular Surgery — Chinese PLA General Hospital et First Affiliated Hospital Zhejiang University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.