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Protocol for the ROBUST (Registry Of type B aortic dissection with the Utility of STent graft) study: an ambispective, multicentre, open cohort study
  1. Dan Rong1,
  2. Yangyang Ge1,
  3. Yan Xue2,
  4. Feng Liu1,3,
  5. Kai Lu1,4,
  6. Peng Liu1,5,
  7. Lei Zhang3,
  8. Xiaohu Ge6,
  9. Jianhang Miu7,
  10. Linkun Zhong7,
  11. Weidong Fan8,
  12. Hongpeng Zhang1,
  13. Xin Jia1,
  14. Xiaohui Ma1,
  15. Jiang Xiong1,
  16. Xiaoping Liu1,
  17. Wei Guo1
  1. 1 Department of Vascular and Endovascular Surgery, Chinese PLA General Hospital, Beijing, China
  2. 2 Department of Cardiovascular Surgery, General Hospital of Armed Police Forces, Beijing, China
  3. 3 Department of Vascular and Endovascular Surgery, The First Hospital of Hebei Medical University, Shijiazhuang, China
  4. 4 Department of Vascular Surgery, Daqing Oil General Hospital, Daqing, China
  5. 5 Department of Vascular Surgery, Affiliated Hospital of Jining Medical University, Jining, China
  6. 6 Department of Vascular Surgery, People’s Hospital of Xinjiang Uygur Autonomous Region, Urumchi, China
  7. 7 Department of General Surgery, Zhongshan People’s Hospital, Zhongshan, China
  8. 8 Department of Cardiology, Henan Provincial Chest Hospital, Zhengzhou, China
  1. Correspondence to Professor Wei Guo; guowei{at}301hospital.com.cn

Abstract

Introduction Thoracic endovascular aortic repair (TEVAR) is widely used for type B aortic dissection, although with satisfactory outcome in a limited proportion of patients. To better inform patient prognostication, the Registry Of type B aortic dissection with the Utility of STent graft (ROBUST) study aims to identify imaging-based predictors of post-TEVAR adverse outcomes up to 10-year follow-up.

Methods and analysis ROBUST is designed as an ambispective, multicentre, open cohort study. All patients undergoing TEVAR from 1 January 2008 to 1 July 2027 at participating centres will be invited to join the study. It is conservatively estimated that over 2000 patients will join the study. Data on demographics, disease history, procedural details, imaging features and follow-up will be collected after discharge. Cox proportional-hazards analysis will be used to identify independent predictors of primary outcomes. Stratification analysis will be performed to identify which subgroup of patients would benefit the most from TEVAR.

Ethics and dissemination The protocol has been approved by the ethics committee of the coordinating centre. Findings will be disseminated in professional peer-reviewed journals to promote understanding of the rehabilitation process.

Trial registration number ChiCTR-POC-17011726; Pre-results.

  • type B aortic dissection
  • thoracic endovascular aortic repair
  • imaging features
  • patient prognostication

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • DR and YG contributed equally.

  • Contributors WG, XL, LZha, XG, JM and WF planned the study. YG, XJ, JX , XM and HZ designed the study. YX, KL and PL provided ethical support. DR and YG registered the study, wrote the study protocol and revised the manuscript. YG, DR, FL and LZho developed the CRF.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval IRB of Chinese PLA General Hospital.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The ROBUST study is an open project. We will share our data after arrangement. We welcome institutions experienced with TEVAR to join the study. Anyone interested in our research can download the data from the website: huiyihuiying.com or contact us directly.

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