WRAPSODY AV access Efficacy (WAVE)

• Research type

  Research Study

• Full title

  WAVE: Prospective, Randomized, Controlled, Multicenter Study Comparing the Merit WRAPSODYTM Endovascular Stent Graft to Percutaneous Transluminal Angioplasty for Treatment of Venous Outflow Circuit Stenosis or Occlusion in Hemodialysis Patients

• IRAS ID

  293124

• Contact name

  Robert Jones

• Contact email

  robert.jones@uhb.nhs.uk

• Sponsor organisation

  Merit Medical Systems, Inc.

• Clinicaltrials.gov Identifier

  NCT03644017

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  3 years, 5 months, 24 days

• Research summary

  This study is designed for patients who have dialysis access circuit blockage that is causing an issue with dialysis sessions. The WRAPSODY Endovascular Stent Graft is an investigational medical device that is permanently placed inside a vein to help keep it open. It is a small tube-shaped device made of a wire frame and covered with materials that help to reduce new tissue from growing inside it, which may delay the vein from narrowing in the same area again.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  21/YH/0057

• Date of REC Opinion

  8 Apr 2021

• REC opinion

  Further Information Favourable Opinion