The Merit WRAPSODY AV Access Efficacy Study (WAVE) (WAVE)

March 20, 2024 updated by: Merit Medical Systems, Inc.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

357

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Brasília, Brazil
        • Instituto Santa Marta De Ensino E Pesquisa
      • Recife, Brazil
        • Real Hospital Português de Beneficência em Pernambuco
      • Rio De Janeiro, Brazil
        • Hospital Universitário Pedro Ernesto
      • São Paulo, Brazil
        • Instituto Dante Pazzanese de Cardiologia
  • Canada
      • Toronto, Canada
        • Toronto General Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Dorchester, United Kingdom
        • Dorset County Hospital
      • London, United Kingdom, E1 1FR
        • Royal London Hospital
      • Oxford, United Kingdom, OX3 7LE
        • Churchill Hospital
      • Stevenage, United Kingdom, SG1 4AB
        • Lister Hospital
  • United States
    • Arizona
      • Tempe, Arizona, United States, 85281
        • Southwest Kidney institute (SKI) Vascular Center
      • Tucson, Arizona, United States, 85718
        • Pima Heart and Vascular
    • California
      • Orange, California, United States, 92868
        • St. Joseph Hospital
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Vascular Care Connecticut
    • Delaware
      • Newark, Delaware, United States, 19713
        • Nephrology Associates
    • Florida
      • Jacksonville, Florida, United States, 32256
        • First Coast Cardiovascular Institute
      • Miami, Florida, United States, 33169
        • Open Access Miami, LLC
      • Ocala, Florida, United States, 34471
        • Leesburg Vascular Access Center & Discovery Medical Research
      • Pensacola, Florida, United States, 32504
        • Coastal Vascular and Interventional
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Center
      • Chicago, Illinois, United States, 60559
        • Chicago Access Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital and Methodist Hospital
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • King's Daughters Medical Center
    • Massachusetts
      • West Roxbury, Massachusetts, United States, 02130
        • Brigham and Women's Faulkner Hospital
    • Michigan
      • Flint, Michigan, United States, 48507
        • Michigan Vascular Access Center
    • New Jersey
      • Vineland, New Jersey, United States, 80360
        • Vascular Institute of Atlantic Medical Imaging
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Health
      • Charlotte, North Carolina, United States, 28202
        • Charlotte Radiology
      • Raleigh, North Carolina, United States, 27607
        • NC Heart and Vascular Research
      • Raleigh, North Carolina, United States, 27610
        • North Carolina Nephrology Raleigh Access
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University Pittsburg Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Providence Access Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health System Upstate
    • Texas
      • Dallas, Texas, United States, 75235
        • Renal Disease Research Institute
      • Dallas, Texas, United States, 75226
        • Soltero Cardiovascular Research Center
      • Fort Worth, Texas, United States, 76104
        • PPG Health PA, DBA-Tarrant Vascular
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77008
        • Global Kidney Associates
      • Katy, Texas, United States, 77494
        • University of Texas Health - Memorial Hermann Katy Hospital
      • Pasadena, Texas, United States, 77504
        • CDVA
      • Plano, Texas, United States, 75093
        • Dallas Nephrology Associates
    • Virginia
      • Virginia Beach, Virginia, United States, 23507
        • Sentara Vascular Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject provides written informed consent
  • Subject is male or female, with an age ≥ 18 years at date of enrollment.
  • Subject is willing to undergo all follow-up assessments.
  • Subject has a life expectancy ≥ 12 months.
  • Subject is undergoing chronic hemodialysis.
  • Subject has either a mature AVF or AVG in the arm.
  • Target lesion(s) involves a de novo stenotic or non-stented restenotic lesion.
  • Target lesion has ≥50% stenosis.
  • Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm

Exclusion Criteria:

  • Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
  • Subject has a stroke diagnosis within 3 months prior to enrollment.
  • Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
  • Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.
  • Target lesion is located within a stent / stent graft.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AVF Peripheral study treatment group
Subjects randomised to treatment with the WRAPSODY Endovascular Stent Graft
Device: Merit WRAPSODY Endovascular Stent Graft
Target lesion treated with stent graft placement
Other: AVF Peripheral control group
Subjects randomised to treatment with standard percutaneous transluminal angioplasty (PTA)
Device: PTA
Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
Experimental: AVG Anastomosis
All subjects in this single arm cohort will receive treatment with the WRAPSODY Endovascular Stent Graft
Device: Merit WRAPSODY Endovascular Stent Graft
Target lesion treated with stent graft placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint)
Time Frame: 30 days
Proportion of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.
30 days
Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)
Time Frame: 6 months
Proportion of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with Target Lesion Primary Patency
Time Frame: 12 and 24 months
12 and 24 months
Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP)
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
Proportion of subjects with Access Circuit Primary Patency (ACPP)
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
Proportion of subjects with Post-Procedure Secondary Patency
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
Rates of procedure- and device-related adverse events involving the access circuit
Time Frame: Index procedure, 30 days, and months 6, 12 and 24.
Index procedure, 30 days, and months 6, 12 and 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merit Medical Systems, Inc.

Investigators

  • Principal Investigator: Robert Jones, MD, The Queen Elizabeth Hospital
  • Principal Investigator: Mahmood K Razavi, MD, St. Joseph's Hospital, Orange, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Actual)

February 22, 2024

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVO-P3-20-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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