ADVANCE Trial

• Research type

  Research Study

• Full title

  EndurAnt Stent Graft system vs ExcluDer endoprothesis: a global, prospectiVe, rANdomized Clinical trial in sac rEgression (ADVANCE Study)

• IRAS ID

  317197

• Contact name

  Dominic Howard

• Contact email

  dominic.howard@ouh.nhs.uk

• Sponsor organisation

  Medtronic

• Duration of Study in the UK

  7 years, 0 months, 1 days

• Research summary

  The ADVANCE study is post-market, prospective, interventional, global,
  multicenter, randomized, dual-arm trial.
  The purpose of the post-market study is to demonstrate clinical benefit with Endurant II/IIs compared to Gore Excluder/Excluder Conformable by generating robust, Level I evidence to elucidate the mechanism of sac regression and any device-related differences, in subjects with Abdominal Aortic Aneurysms (AAA) for whom an EVAR procedure is indicated. Beyond comparing sac regression rates between devices, the study will also investigate if the sac regression led to decreased risk or hazard of secondary interventions and mortality.
  The Endurant Stent Graft System family, consisting of the Endurant II/IIs, are stent graft systems which have been designed for the endovascular repair of aneurysms.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  23/EE/0068

• Date of REC Opinion

  16 May 2023

• REC opinion

  Further Information Favourable Opinion