Protocol for Guo's 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)

Feng Liu, Hongpeng Zhang, Dan Rong, Yangyang Ge, Xin Jia, Jiang Xiong, Xiaohui Ma, Lijun Wang, Tingting Fan, Wei Guo, Feng Liu, Hongpeng Zhang, Dan Rong, Yangyang Ge, Xin Jia, Jiang Xiong, Xiaohui Ma, Lijun Wang, Tingting Fan, Wei Guo

Abstract

Introduction: Endovascular repair of the entire aortic arch provides treatment opportunities for patients with aortic arch lesions who are intolerant to open surgery. However, the complex anatomical configuration, high-speed blood flow and long access from the femoral artery increase the difficulty of endovascular aortic arch repair. On the basis of our earlier studies, a new modular inner branch stent-graft system was developed specifically for lesions located in the aortic arch and part of the ascending aorta. 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.

Keywords: cardiothoracic surgery; protocols & guidelines; vascular surgery.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Design of the new modular inner branch stent-graft and delivery system. The modular stent-graft before (A) and after (B) assembly. The dedicated delivery systems are shown for ascending aorta stent-grafting (upper image in panel C; pre-curved design) and aortic arch stent-grafting (lower image in panel C; pre-curved plus steerable design). Schematic diagram of the steering operation of the pre-curved plus steerable delivery system (D). First, ascending aorta stent-graft; second, bridging cover-stents; third, aortic arch stent-graft. The arrow indicates the control dial that is used to steer the direction of the tip.
Figure 2
Figure 2
Schematic diagram of the endovascular procedure. A–C, Module 1 is deployed in the ascending aorta, and the two inner branches of the endograft self-align with the anterior aspect of the ascending aorta. D–F, Module 2 is deployed to bridge the inner branches of module 1 to the supra-aortic arteries via the right brachial and left common carotid artery accesses, respectively. G–I, Module 1 is deployed to overlap the lumen of module 1 via a steerable pre-curved delivery system, and the proximal portion of the left subclavian artery is embolised using coils.

References

    1. Settepani F, Cappai A, Basciu A, et al. . Outcome of open total arch replacement in the modern era. J Vasc Surg 2016;63:537–45. 10.1016/j.jvs.2015.10.061
    1. Yoshitake A, Okamoto K, Yamazaki M, et al. . Comparison of aortic arch repair using the endovascular technique, total arch replacement and staged surgery†. Eur J Cardiothorac Surg 2017;51:1142–8. 10.1093/ejcts/ezx028
    1. Czerny M, Schmidli J, Adler S, et al. . Editor's Choice – Current options and recommendations for the treatment of thoracic aortic pathologies involving the aortic arch: an expert consensus document of the European Association for Cardio-Thoracic Surgery (EACTS) & the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 2019;57:165–98. 10.1016/j.ejvs.2018.09.016
    1. Andrási TB, Grossmann M, Zenker D, et al. . Supra-Aortic interventions for endovascular exclusion of the entire aortic arch. J Vasc Surg 2017;66:281–97. 10.1016/j.jvs.2017.04.024
    1. Ishimaru S. Endografting of the aortic arch. J Endovasc Ther 2004;11 Suppl 2:II-62–II-71. 10.1177/15266028040110S609
    1. Hui DS, Fleischman F. Diagnostic and treatment dilemmas of the aortic arch. Cardiol Clin 2017;35:347–55. 10.1016/j.ccl.2017.03.012
    1. Tanaka A, Estrera A. Endovascular treatment options for the aortic arch. Cardiol Clin 2017;35:357–66. 10.1016/j.ccl.2017.03.005
    1. Makaloski V, Tsilimparis N, Rohlffs F, et al. . Endovascular total arch replacement techniques and early results. Ann Cardiothorac Surg 2018;7:380–8. 10.21037/acs.2018.04.02
    1. Tazaki J, Inoue K, Higami H, et al. . Thoracic endovascular aortic repair with branched Inoue stent graft for arch aortic aneurysms. J Vasc Surg 2017;66:1340–8. 10.1016/j.jvs.2017.03.432
    1. Blanco Amil CL, Mestres Alomar G, Guarnaccia G, Amil CLB, Alomar GM, et al. . The initial experience on branched and fenestrated endografts in the aortic arch. A systematic review. Ann Vasc Surg 2021;75:29-44. 10.1016/j.avsg.2021.03.024
    1. De Freitas S, Rossi MJ, Abramowitz SD, et al. . Systematic review and meta-analysis of endovascular interventions for Stanford type A aortic dissection. J Vasc Surg 2021;74:1721–31. 10.1016/j.jvs.2021.01.054
    1. Ahmed Y, Houben IB, Figueroa CA, et al. . Endovascular ascending aortic repair in type A dissection: a systematic review. J Card Surg 2021;36:268–79. 10.1111/jocs.15192
    1. Inoue K, Hosokawa H, Iwase T, et al. . Aortic arch reconstruction by transluminally placed endovascular branched stent graft. Circulation 1999;100:Ii316–21. 10.1161/circ.100.suppl_2.Ii-316
    1. Furuta A, Azuma T, Yokoi Y, et al. . The midterm results of thoracic endovascular aortic repair with a precurved fenestrated endograft in zone 0–1. Eur J Cardiothorac Surg 2020;58:722–9. 10.1093/ejcts/ezaa165
    1. Yokoi Y, Azuma T, Yamazaki K. Advantage of a precurved fenestrated endograft for aortic arch disease: simplified arch aneurysm treatment in Japan 2010 and 2011. J Thorac Cardiovasc Surg 2013;145:S103–9. 10.1016/j.jtcvs.2012.11.058
    1. Bosse C, Kölbel T, Mougin J, et al. . Off-the-shelf multibranched endograft for total endovascular repair of the aortic arch. J Vasc Surg 2020;72:805–11. 10.1016/j.jvs.2019.11.046
    1. Spear R, Haulon S, Ohki T, et al. . Editor's Choice - Subsequent results for arch aneurysm repair with inner branched endografts. Eur J Vasc Endovasc Surg 2016;51:380–5. 10.1016/j.ejvs.2015.12.002
    1. van der Weijde E, Heijmen RH, van Schaik PM, et al. . Total endovascular repair of the aortic arch: initial experience in the Netherlands. Ann Thorac Surg 2020;109:1858–63. 10.1016/j.athoracsur.2019.09.009
    1. Czerny M, Rylski B, Morlock J, et al. . Orthotopic branched endovascular aortic arch repair in patients who cannot undergo classical surgery. Eur J Cardiothorac Surg 2018;53:1007–12. 10.1093/ejcts/ezx493
    1. Planer D, Elbaz-Greener G, Mangialardi N, et al. . Nexus arch: a multicenter study evaluating the initial experience with a novel aortic arch stent graft system. Ann Surg 2021. 10.1097/SLA.0000000000004843. [Epub ahead of print: 04 Mar 2021].
    1. D'Onofrio A, Antonello M, Lachat M, et al. . Endovascular treatment of aortic arch aneurysm with a single-branched double-stage stent graft. J Thorac Cardiovasc Surg 2017;154:e75–7. 10.1016/j.jtcvs.2017.06.030
    1. Guo W, Zhang H, Liu X, et al. . Endovascular repair of aortic arch aneurysm with a new modular double inner branch stent graft. Ann Vasc Surg 2021;77:347.e1-347.e5. 10.1016/j.avsg.2020.05.053
    1. Guo W, Liu X, Liang F, et al. . Transcarotid artery endovascular reconstruction of the aortic arch by modified bifurcated stent graft for Stanford type A dissection. Asian J Surg 2007;30:290–5. 10.1016/S1015-9584(08)60042-1
    1. Wei G, Xin J, Yang D, et al. . A new modular stent graft to reconstruct aortic arch. Eur J Vasc Endovasc Surg 2009;37:560–5. 10.1016/j.ejvs.2009.01.017
    1. Banks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke 2007;38:1091–6. 10.1161/01.STR.0000258355.23810.c6
    1. Ferrer C, Cao P, Coscarella C, et al. . iTalian registry of doUble inner branch stent graft for arch pathology (the triumph registry). J Vasc Surg 2019;70:672–82. 10.1016/j.jvs.2018.11.046
    1. Zafar MA, Chen JF, Wu J, et al. . Natural history of descending thoracic and thoracoabdominal aortic aneurysms. J Thorac Cardiovasc Surg 2021;161:498–511. 10.1016/j.jtcvs.2019.10.125
    1. Elefteriades JA. Natural history of thoracic aortic aneurysms: indications for surgery, and surgical versus nonsurgical risks. Ann Thorac Surg 2002;74:S1877–80. 10.1016/S0003-4975(02)04147-4

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する