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The Merit WRAPSODY AV Access Efficacy Study (WAVE)

NCT04540302 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2025-04-13

No results posted yet for this study

Summary

The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit

Conditions

  • Venous Stenosis
  • Venous Occlusion

Interventions

DEVICE

Merit WRAPSODY Endovascular Stent Graft

Target lesion treated with stent graft placement

DEVICE

PTA

Target lesion treated with standard percutaneous transluminal angioplasty (PTA)

Sponsors & Collaborators

  • Merit Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Mahmood K Razavi, MD · St. Joseph's Hospital, Orange, CA

  • Robert Jones, MD · The Queen Elizabeth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2024-02-22
Completion
2026-01-31
FDA Device
Yes

Countries

  • United States
  • Brazil
  • Canada
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04540302 on ClinicalTrials.gov