WRAP Registry

• Research type

  Research Study

• Full title

  Prospective, multicenter, observational study to evaluate the Merit WRAPSODY™ Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft (The WRAP Registry)

• IRAS ID

  306084

• Contact name

  Vicky Brunk

• Contact email

  vicky.brunk@merit.com

• Sponsor organisation

  Merit Medical Systems, Inc.

• Clinicaltrials.gov Identifier

  NCT05062291

• Duration of Study in the UK

  3 years, 0 months, 2 days

• Research summary

  The WRAP registry is an observational study that will collect clinical data on patients who have been treated with the WRAPSODY Endoprosthesis device for stenosis or occlusion within dialysis arteriovenous circuits in a real-world setting.
  The purpose of the registry is to further determine the safety and effectiveness of the CE marked device, to describe the procedure and patient outcome of patients worldwide, to identify rare events and look for predictors of adverse events.
  The registry is inviting patients from centres across the world to participate. No additional tests or procedures are required, all treatment will be according to hospital routine practice. Data will be collected and analysed up to 24 months following the procedure.

• REC name

  Wales REC 5

• REC reference

  21/WA/0377

• Date of REC Opinion

  26 Nov 2021

• REC opinion

  Favourable Opinion