GORE® VIAFORT Vascular Stent VNS 21-05

• Research type

  Research Study

• Full title

  Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Inferior Vena Cava Obstruction with or without Combined Iliofemoral Obstruction.

• IRAS ID

  313557

• Contact name

  Stephen Black

• Contact email

  stephen.black@gstt.nhs.uk

• Sponsor organisation

  W.L Gore and Associates Inc.

• Clinicaltrials.gov Identifier

  NCT05409976

• Duration of Study in the UK

  6 years, 2 months, 0 days

• Research summary

  This is a prospective, non-randomized, multicentre, single- arm, global clinical study where 111 patients will be recruited across approximately 20 sites. The primary aim of the study is to assess patients who have been treated with the the GORE® VIAFORT Vascular Stent for the treatment of symptomatic inferior vena cava obstructions, with or without combined iliofemoral obstruction. Assessments carried out will be used to establish the safety and effectiveness of the device.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  22/LO/0650

• Date of REC Opinion

  1 Nov 2022

• REC opinion

  Further Information Favourable Opinion