EXCeL registry

• Research type

  Research Study

• Full title

  GORE® EXCLUDER® Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms

• IRAS ID

  254788

• Contact name

  Jenny Zwetsloot

• Contact email

  jenny.zwetsloot@catharinaziekenhuis.nl

• Sponsor organisation

  Stichting Wetenschappelijk Onderzoek Chirurgie Catharina Ziekenhuis

• Clinicaltrials.gov Identifier

  NCT03743142

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  3 years, 4 months, 1 days

• Research summary

  EVAR continues to evolve as a treatment option for AAA. New devices which are specifically designed to perform adequately across the spectrum of potential anatomic presentations for infrarenal EVAR are needed. The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the EXCeL Registry.
  This study will assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (CEXC Device) in patients who meet the IFU anatomic criteria (≥15mm proximal neck length and ≤90˚ proximal neck angulation; and ≥10mm proximal neck length and ≤60˚ proximal neck angulation) and in patients with challenging anatomic presentation that may present outside the IFU anatomic criteria (see Table A below). Successful outcomes from this study will provide evidence to support the CEXC Device as an option for expanding EVAR to a broader patient population with more challenging anatomic presentations.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  19/NW/0114

• Date of REC Opinion

  25 Apr 2019

• REC opinion

  Further Information Favourable Opinion