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

  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.

  Summary of Results:

  General information about the research

  Study Title
  A study comparing the WRAPSODY stent graft to standard balloon treatment in patients with dialysis access blockages.

  Who carried out the research?
  This study was sponsored by Merit Medical Systems, Inc. and conducted by clinical investigators at multiple hospitals and research centers.

  Where and when did the study take place?
  The study was conducted at 43 sites in the United States, Canada, Brazil, and the United Kingdom. The first patient was enrolled in March 2021 and the study was completed in August 2025[VB1.1].

  Why was the research needed?
  Patients who require dialysis often develop narrowing or blockage in the blood vessels used for treatment. Current standard treatment (balloon angioplasty) may not keep the vessel open for long. This study was needed to determine whether the WRAPSODY stent graft could provide a longer-lasting solution.

  What were the main questions studied?
  • Does the WRAPSODY stent graft keep blood vessels open longer than standard balloon treatment?
  • Is the safety profile of WRAPSODY stent graft comparable to standard treatments?

  Who participated in the study?
  A total of 357 patients took part. All participants required treatment for narrowing or blockage in the blood vessels used for dialysis access.

  What treatments did participants receive?
  There were 2 different patient groups based on dialysis access type and the vessel that needed treatment.
  1. Patients with arteriovenous fistula (AVF) who will be treated in the arm (AVF Cohort).
  Participants in this group were randomly assigned to be treated with either the WRAPSODY stent graft or standard balloon angioplasty
  2. Patients with arteriovenous graft (AVG) who will be treated in the arm (AVG Cohort). All participants in this group were treated with the WRAPSODY stent graft.

  What happened during the study?
  Participants underwent their assigned treatment and were followed over time. They attended clinic visits and follow-up assessments at regular intervals up to 24 months after treatment to monitor their health and the condition of their dialysis access.

  What medical problems (adverse reactions) did participants have?
  Serious medical events were common in this group of patients, which is expected due to their underlying health conditions. The most common events were problems with the dialysis access site, such as narrowing or clotting that is also consistent with standard treatment options.

  Rates of death and serious complications were similar across all treatment groups. Complications directly related to the device or procedure occurred less often in patients treated with the WRAPSODY stent graft.

  What were the results of the study?
  WRAPSODY was more effective at keeping blood vessels open over time, referred to as patency:
  • At 6 months, significantly more AVF patients (89.6%) treated with WRAPSODY, maintained an open vessel compared to those treated with balloon (62.3%).
  • At 6 months, 81.4% of AVG patients treated with WRAPSODY maintained an open vessel.
  At 30 days, the rate of significant complications was comparable across all treatments. Patients treated with WRAPSODY continued to have better patency at 12 months and 24 months compared to balloon angioplasty.

  How has this study helped patients and researchers?
  This study provides evidence that the WRAPSODY stent graft can keep dialysis access vessels open longer than standard treatment without increasing overall risk. These findings may help doctors choose more effective treatment options and support future research and regulatory decisions.

  Details of any further research planned
  Further studies of outcomes with the WRAPSODY stent graft in broader patient populations to better understand long-term outcomes and real-world use are ongoing.

  Where can I learn more about this study?
  More information is available on ClinicalTrials.gov:
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04540302%2FNBTI%2FhK-FAQ%2FAQ%2F1ce29233-7150-4d17-80a2-269cbde34e51%2F1%2FdreOzMJoq3&data=05%7C02%7Csheffield.rec%40hra.nhs.uk%7C59be8619dc634fdcb33608debda9528a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639156732093988914%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=9OpZ9foAUEiXdAyg9WcPHnEOScBbSmoc%2F1Cg%2FzpxOoM%3D&reserved=0

• 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